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Atherosclerosis Risk in Communitiee Study Protocol Manual 6a Ultrasound Assessment: Scanning Procedures Visit 3 Version 3.0 January 1995 For Copies, Please Contact ARIC Coordinating Center Department of Biostatistics (CSCC) University of North Carolina at Chapel Hill CBX 8030, Suite 203, NationsBank Plaza Chapel Hill, NC 27514 FOREWORD This manual, entitled Ultrasound Assessment: Scannina Procedures is one ofa series of protocols and manuals of operation for the AtherosclerosisR i s k in Corninunities (ARIC) Study. The complexity of the ARIC Study requires that a sizeable number of procedures be described, thus this rather extensive list of materials has been organized into the set of manuals listed below. Manual 1 provides the background, organization, and general objectives of the ARIC Study. Manuals 2 and 3 describe the operation of the Cohort and Surveillance Components of thestudy. Detailed Manuals of Operation for specific procedures, including those of reading centers and central laboratories, make up Manuals 4 through 11 and 13 through 15. Manual 12 on Quality Assurance contains a general description of the study's approach t o quality assurance as well as the details for quality control for the different study procedures. ARIC Study Protocols and Manuals of Operation MANUAL 1 General 2 Cohort Component Procedures 3 Cohort and Community Surveillance 4 Pulmonary Function Assessment S Electrocardiography 6 Ultrasound Assessment a. Ultrasound Scanning Procedures b. Ultrasound B-mode Image Reading Protocol c. Distensibility Scanning Protocol (Retired) d. Distensibility Reading Protocol (Retired) Description and Study Management - (Retired) - - 7 Blood Collection and Processing 8 Lipid and Lipoprotein Determinations 9 Hemostasis Determinations Determinations - 10 Clinical Chemistry (Retired) 11 Sitting Blood 12 Quality Assurance and Quality Control 13 Magnetic Resonance Imaging a. Magnetic Resonance Imaging Protocol b. Magnetic Resonance Imaging Reading Protocol 14 Retinal Photography 15 Echocardiography Pressure MANUAL 6A TABLE OF CONTENTS 1 . 1 . 3. 2 2 4 ULTRASOUND AREA INSTRUMENTATION 3.1 The Biosound Phase 2 Ultrasound Imaging System 3.2 The Video Cassette Recorder 3.3 The M I Tissue-Mimicking Ultrasound Phantom 3.4 The 486-SX Computer 3.5 The Study Flow Program 3.6 IBM-XT Computer 3.7 Dinamap Automated Blood Pressure Apparatus . 5 ....... ....... . . . . . . . . . .. .. .. .. .. .. .. .. . . . . . . . . . . . . . .. .. .. .. .. .. .. ............ . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. EQUIPMENT MAINTENANCE 4.1 Biosound Phase 2 Ultrasound Imaging System 4.2 VideoCassetteRecorder 4.3 RMI 414 B Tissue Mimicking Ultrasound Phantom 4.4 486-SX Computer 4.5 IBM-XT 4.6 Dinamap Automated Blood Pressure ......... .................. ........ ....................... ........................... .............. . DAILY PRELIMINMIES . . . 5.1 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Biosound Phase 2 setup . . . . . . . . . . . . . . . . . . . 5.3 6 . 7 . Supplies 0 .......................... ARTERIAL SITES AND ANATOMIC STRUCTURES TO BE EXAMINED 6.1 Priority for Boundary Visualization 6.2 The Carotid Arteries 6.3 Cursor Placement by Site and Side ............. .................... .............. . ...... ..................... ..................... .................. ....................... PARTICIPANT PRELIMINARIES 7.1 Participant Orientation to Ultrasound Examination 7.2 Participant Apparel 7.3 Study Preliminaries 7.4 Preliminary Questionnaire 7.5 BloodPressure 7.6 Preparation €or Ultrasound Examination ........... a . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 10 . 9 10 21 21 21 23 24 24 24 27 36 36 36 36 37 38 46 CAROTIDSCANS 8.1 Calibration 8.2 Right Carotid Scan 8.3 Left Carotid Scan 8.4 QuestionScreens 8.5 Ultrasound Conclusion 56 56 57 61 65 65 SONOGRAPHER TRAINING. CERTIFICATION AND MONITORING 9.1 Training 9.2 Certification 9.3 Monitoring 9.4 The B-Mode Study Scan Evaluation Form 9.5 The Lead Study Sonographer 74 74 75 79 80 80 ..................... ...................... ...................... .................... 9 6 6 6 6 9 .......................... ........................ ......................... ............ ................. 81 . 11 . . . . .. . . . . LABELING AND MAILING TO THE ULTRASOUND READING CENTER 11.1 Labeling of Video Cassettes and Diskettes 11.2 Content of Mailing 11.3 Frequency of Mailing 11.4 Package Labeling 11.5 Verification of Mailing Contents 82 82 82 82 83 83 ..................... .................... . . . ... . . . . . . . . . . . . . . . . . .............. 12 . 14 . POLICIES/PROCEDURES FOR REPORTING B-MODE ULTRASOUND RESULTS 12.1 Routine Reporting 12.2 Procedures for Non-routine Results .... 84 84 84 ..................... ............. ........................... . . . ................. ................. ................ ... ............... ........... APPENDICES APPENDIX I: DOPPLER SIGNAL ID OF THE INTERNAL CAROTID ARTERY APPENDIX 11: SOFTWARE TROUBLESHOOTING APPENDIX 111: TROUBLESHOOTING APPENDIX IV: BIOSOUND KEYBOARD APPENDIX V: LOG SHEET REFERENCE APPENDIX VI: VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM APPENDIX VII: WEEKLY SHIPPING LOG APPENDIX VIII: INFORMATION REFERENCE SHEET APPENDIX IX: READING LIST A - 1 A - 1 A - 2 A - 5 A - 6 A - 7 A 10 A 12 A 13 ...................A . . . .15 iii MANUAL 6A LIST OF FIGURES Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure . . . . . .. . 1 2 3 4 5 6 7 8 . . . 9 10 11 12 13 14 15 16 17 . . . . . Figure 18 . Figure 19 . Figure 20 . Figure 21 . Figure 22 . Figure 23 . Figure 24 . Figure 25 . Figure 26 . Figure 27 . . 29 . Figure 28 Figure ..... .... .. ...... Ultrasound Assessment Equipment: Sonographers's Box Ultrasound Assessment Equipment: Biosound Phase 2 VCR Ultrasound Assessment Equipment: Biosound Phase 2 Printer Ultrasound Assessment Equipment: DINAMAP Monitor Ultrasound Assessment Equipment: Computer .PC 486 Ultrasound Assessment Equipment: Tower PC 486 Ultrasound Assessment Equipment: Computer IBM-XT Ultrasound AssessmentEquipment: Cabling Connections Reference Phantom Placement Cross Section or Transverse View of 6 mm Phantom Target Phantom Filament Images Schematic of CarotidArtery Segments Interrogated Common Carotid Artery (all four boundaries visualized) TheBifurcation Doppler Tracing: Internal Carotid Artery Doppler Tracing: External carotid Artery Doppler tracing: Combination of Internal and External Carotid Biosound Screen Calibration Procedure Image As Seen OnBiosound Monitor: Proper Cursor Placement Blood Pressure Cuff Placement .Left Ankle Blood Pressure Cuff Placement .Right Ankle Right Carotid Artery .Transverse Scan Investigation Procedure Right Carotid Artery .Transverse Scan Investigation Procedure Right Carotid Artery.Transverse Scan Investigation Procedure Right Carotid Artery.Transverse Scan Investigation Procedure L Left Carotid Artery Transverse Scan Investigation Procedure Left Carotid Artery Transverse Scan Investigation Procedure Left Carotid Artery Transverse Scan Investigation Procedure Left Carotid Artery.Transverse Scan Investigation Procedure . . . .. .. .. .. .. ...... .......................... ...................... .. .................. ..... .. ............ ......... ......... ......... .......................... ........... ........ ....... ......................... ......................... .......................... ....... ................. . ......................... . ......................... . ......................... ......................... 11 12 13 14 15 16 17 18 19 20 20 30 31 32 33 33 34 34 35 54 55 66 67 68 69 70 71 72 73 1 1. INTRODUCTION Theultrasoundexaminationofthe ARIC c o h o r t p a r t i c i p a n t s c o n s i s t s of t h e f o l l o w i n gc o m p o n e n t s : (1) u l t r a s o n i ci m a g i n go ft h e c a r o t i d arteries i n t h e n e c ka n d ( 2 ) m o n i t o r i n g of a r t e r i a l blood p r e s s u r e t h r o u g h o u t t h e u l t r a s o u n d protocol d e t a i l sb o t ht y p e so fp r o c e d u r e s .A d d i t i o n a l e x a m i n a t i o n .T h i s i n s t r u c t i o n s f o r m o n i t o r i n g a r t e r i a l blood p r e s s u r e are d e t a i l e d i n t h e i s i n c l u d e dw i t he a c hD i n a m a p (Model 1846SX) Dinamap S e r v i c eM a n u a l ,w h i c h u n i t .I n t e r p r e t a t i o no ft h eu l t r a s o u n de x a m i n a t i o np e r f o r m e d at the (URC) i s d e s c r i b e d i n t h e U l t r a s o u n d A s s e s s m e n t P a r t U l t r a s o u n dR e a d i n gC e n t e r 2: R e a d i n gP r o t o c o l . ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - Visit 3 VERSION 3.0 01/95 2 2. SELECTION OF ULTRASOUND SYSTEM The ultrasound system selected for use in the ARIC Visit 1 (1987-1989) and Visit 2 (1990-1992) exams was the Biosound 2000 11. Selection of the Biosound 2000 I1 was based on the results a of series of detailed protocols performed on systems provided by four different manufacturers, and included in-vitro tests on excisedarteries, measurement of the transmitted pressure pulse with a miniature hydrophone transducer, routine system performance measurements On phantom test objects, and in-vivo evaluations which included considerations of ease of use by thesonographer. The ultrasound system selected forARIC Visit 3 (1993-1995) is theBiosound Phase 2. The Biosound Phase 2 is the updated model of the Biosound 2000 11. It was chosen because the older model is no longer manufactured and maintenance of a high performance level in the 2000 I1 would be increasingly difficult t o achieve during thisVisit. The Phase 2 performs essentially the same as the Biosound 2000 11. The improvements include a lighter transducer probe, an extended (deeper) field of view, improved gray scale presentationand a closer adherence t o t h eNTSC standards for video signals. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 3 3. ULTRASOUND AREA INSTRUMEWTATION ultrasound The ultrasound area instrumentation consists of a Biosound 2Phase imaging system, an NEC PC 1/2" Video Cassette Recorder, an M I 414B Tisaue Mimicking Ultrasound Phantom, a 486-SX computer, an IBM-XT computer, a Dinamap automated blood pressure machine and a computer software atudy flow program. The e-[uipment was designed and selected to assist the sonographer in adhering to thz protocolsteps. Figures are presented at the end of Section 4, including a "Cabling ConnectionsReference". A brief description of each piece of equipment follows. 3.1 The Biosound Phase 2 Ultrasound Imaging System The Biosound Phase2 system is a high resolution ultrasound imaging system designed for relatively.shallowanatomical structures such as the extracranial carotid arterial system. Images of the arteries are obtained using a nominal 8 MHz transducer driven by a motor in a sector scan format. The sector scan format is presented in a rectilinear format with a nominallateral view of 2 cm and a depth of5 cm. . I n addition to theB-mode image, Doppler signals from the arteries can be obtained, processed and displayed in a frequency versus time format. The Doppler information is used primarily €or arterial identification. An 1/2* sVHS video cassette recorder (VCR)is connected to the Biosound Phase 2. The VCR records the ultrasound video information coming from the video channel onto the video cassette. 3.2 The Video Cassette Recorder The video recorderis an NEC 1/2" sVHS PC-VCR. It was chosen to provide superior image quality cassettes. The sVHS cassettes are sent to the Ultrasound Reading Centerfor interpretation. 3.3 The RMI Tissue-Mimicking Ultrasound Phantom A modified RMI414B tissue mimicking ultrasound phantom with water trough attachment is used periodically for performance checks on the Biosound Phase 2. The phantom has arterial mimicking targets of various diameters and depths. These targets can bescanned from both longitudinal and transverse directions, and the images and video information can be evaluatedto assess system performance. The images are recorded on 1/2" sVHS video cassettes and Sent t o t h eUltrasound Reading Center. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 4 3.4 The 486-SX Computer The 486-SX computer is used for multiple purposes in the ultrasound area. The computer interacts with the sonographer and ultrasound area equipment to perform the followingtasks: a. b. C. d. e. To obtain participant data, such as identification number, birth date, .race, and gender. To establish files for participantdata with appropriate names and file extensions. To keep a record of the study steps performed, including quality assurance studies, from the study flow program. To determine the frequency of quality assurance studies and the arterial sites where the quality assurance studies are performed. TO record data on hard disk for temporary storage and on diskette to send to the Ultrasound Reading Center. The sonographer interacts with the computer during the initial questionnaire and at the completion of the study. The study flow program interfaces with the IBM-XTto control the Dinamap blood pressure monitor and to control the VCR operation. Instructionson the computer screen from the study flow program determine whento take blood pressures manually. At other times, blood pressures are taken automatically by the Dinamap under computer control. The computer controls the PC-VCR video cassette recorder. The primary purpose of the PC-VCR is to record theB-scan video images for reading at the Ultrasound Reading Center; however, it performs additional tasks. It records audio commentsof the sonographers as the scan progresses the forultrasound readers to aid them in the interpretation of recorded B-mode images. A s the B-scan imagesare being recorded,the PC-VCR labels the tape with an address on a frame-by-frame basis. The frame address is used at the reader station for frame identification and to compare frame selection among readers. A sonographer box transmits signals to the 486 computer. These signals, initiated either by push buttons or foot switches, advance the study flow program throughthe steps of the scanning program. When the sonographer has acquired the best images obtainable at a site, the sonographer footswitch is pressed and detected by the computer. The frame address on the video tape is and readstored, and an audio tone is placed on the audio channel. The frame address is later placed fi'le in afor use at the reader station. The audio tone identifies portions of the video cassette that the sonographer feels are the best obtainable views of a site and aids and/or reviewers in finding particular sections on thecassette. 3.5 The Study Flow Program The B-mode ultrasound examination consists of bilateral carotid artery studies and involves a minimum of 10 steps, performed in a similar sequence for each participant. A study flow program assists the sonographer during the examination by formatting and displaying computer screens showing tosteps be completed and steps which have been completed. A manual override box is available for making any changes in the programmed sequence. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 reader 5 3.6 IBM-XT Computer The IBM-XT computer is used to initiate the Dinamap for blood pressure measurements. All measurement results are stored on the IBM-XT until the ultrasound exam is over. The results arestored on a 5 114" floppy disk. That floppy is inserted into theAI drive on the 486 computer and transferred t o a -112" 3 floppy fortransfer to theUltrasound Reading Center. 3.7 Dinamap Automated Blood Pressure Apparatus A series of blood pressure measurements is made during the ultrasound examination. The purposes are to provide baseline supine, seated, and standing blood pressure measurements and to estimate anankle-arm index. Blood pressure is measured using the Dinamap Model 1846 SX, an automated, oscillometric device. The Dinamap Operation Manual should be read carefully before performing the blood pressure measurements. The timing of blood pressure measurements and the sequencing of the Dinamap Model 1846 SX are determined by the IBM-XT. The Dinamap Servicemanual is included witheach machine at the time of purchase. If that manual is lost, another can be orderedfrom the Dinamap zone office. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 4. EQUIPMEW MAINTENANCE E q u i p m e n tm a i n t e n a n c e i s p e r f o r m e dp e r i o d i c a l l y . Detailed r e c o r d s of m a i n t e n a n c e are t o be k e p t a t e a c h f i e l d c e n t e r b y t h e c h i e f s o n o g r a p h e r . 4.1 B i o s o u n dP h a s e 2 Ultrasound Imaging System is r e q u i r e d t o haveBiosoundrepresentativesperform a Each field center p r e v e n t i v em a i n t e n a n c ec h e c kf o u r times a y e a r , a n d t o s e n d copies o f a l l Biosound r e p o r t s t o t h eU l t r a s o u n dR e a d i n gC e n t e r . More f r e q u e n t service v i s i t s may be required i f a n y p r o b l e m s o c c u r b e t w e e n s c h e d u l e d p r e v e n t a t i v e maintenancevisits. The a i r f i l t e r o nt h eB i o s o u n d P h a s e 2 i s r e m o v e da n dc l e a n e dm o n t h l y .T h i s h e l p s t o encourage a i r f l o w t o keeptheequipment cool a n d operating more reliably. Thetransducerhead i s t o be e x a m i n e d f o r a i r b u b b l e s d a i l y before s c a n n i n g is attempted. F o l l o wB i o s o u n dp r o c e d u r e s t o remove a i r b u b b l e s . 4.2 Video Cassette Recorder The Video Cassette R e c o r d e r s h o u l d be c l e a n e d e v e r y s i x m o n t h s b y a Biosound to the field technician during one of their preventive maintenance visits center. 4.3 MI 4 1 4 B Tissue MimickingUltrasoundPhantom The RXI 414B phantom i s checkedweekly t o be s u r e a l l seals are t i g h t a n d t h a t care a n d t h et i s s u em i m i c k i n gg e li n s i d eh a sn o td r i e do u t .P r o p e r t e s t phantom i s d e s c r i b e d i n t h e i n s t r u c t i o n m a n u a l maintenanceofthe accompanyingthephantom.Thephantoms are stored i n a n a i r t i g h t , resealable p l a s t i c c o n t a i n e r . A f e wd r o p s of water o r a w e t s p o n g es h o u l d be added t o t h i s c o n t a i n e r b e f o r e s e a l i n g t o minimize desiccation of t h e ' t i s s u e m i m i c k i n g material. P h a n t o ms p e c i f i c a t i o n s are f o u n di nt h ep h a n t o mi n s t r u c t i o nm a n u a l . Ultrasound Equipment Performance Check 4.3.1 An o n g o i n g q u a l i t y a s s u r a n c e c h e c k of B i o s o u n d i n s t r u m e n t s i s p e r f o r m e d twice a month a t e a c h f i e l d c e n t e r . T h i s i s a c c o m p l i s h e db y a s c a n of i d e n t i c a l RXI T i s s u eM i m i c k i n gP h a n t o m s .T h e scans a r e s e n t t o t h e u l t r a s o u n d R e a d i n g Centerforevaluationandconsist of o n e s c a n of a 6 mm diameter s i m u l a t e d a set of f i l a m e n t s w i t h i n t h e v e s s e l w i t h i n t h e p h a n t o ma n do n es c a no f phantom. T h ef o l l o w i n gi n s t r u m e n tp e r f o r m a n c e protocol i s doneby a c e r t i f i e d s o n o g r a p h e r a t e a c h f i e l d center o n t h e s e c o n d a n d f o u r t h W e d n e s d a y s a f t e r t h e B i o s o u n du l t r a s o u n ds y s t e mh a sb e e np e r m i t t e d t o w a r m u p f o r a t l e a s t 30 m i n u t e s .I na d d i t i o n ,t h e procedure i s a l w a v sr e p e a t e da f t e rt h ef o l l o w i n g : a. b. A f t e r a m a n u f a c t u r e r ' ss e r v i c e c a l l i s performed on t h eB i o s o u n d instrument, A f t e trh et r a n s d u c e r is repaired or replaced. A log i s maintained t o i n s u r e t h e s e tests are p e r f o r m e d per t h e a b o v e schedule. ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 7 The scan of identical phantoms at each field center provides dataanfor ongoing quality assurance program to monitor the performance of each Biosound instrument. Through this program, uniform standards are maintained throughout the project. The RMI 414B ultrasound phantom is placed upright on the examination table of the rectangular case parallel to the longer side of the with the LONG side table. The end of the phantom containing the filaments ranging from 0.5 to 4.0 cm should be positioned closest to the head of the table. (Figure 9). The top surface of the phantom is cleaned with a damp cloth or paper to towel remove residue. The water tray on the top of the phantom is half-filled with tap water to permit efficient coupling of the ultrasound transducer to the tissue equivalent medium. DO NOT USE GEL AS THE COUPLING MEDIUM. Minimal pressure is exerted on the phantom surfacethe with transducer throughout the scan. Excessive pressure or gel on the phantom surface can cause severe damage to the phantom. two minute segment of B-mode phantom images is recorded during this described below. Use a separate sVHS video tape to record phantom images. Selected frames are read at the Ultrasound Reading Center to quantitatively document the ultrasound system imaging characteristics. A : a check Set the VCR display screen to be sure the channel display is set at L. If the "L" is not displayed-, pressthe upand down arrowkeys on the VCR keyboard labeled "Channel" until it does appear. Press the letter "D" on the Phase 2 keyboard and wait€or Main Menu to appear on the bottomof the right monitor screen of the 2. Phase Select PROBE1, located on the Phase 2 keyboard. Make sure the "LUT LN" setting is on the third line the right of Phase2 monitor. If the "LUTLN'* is not present, press the blue IMAGE PROCESS key and select "LINEAR". "LUT LN" will be displayedthe in upper right portion of the keys located at the top Of screen. (Note: The Menu keys are the five black the Phase 2 keyboard.) Check the image orientation. It must be in standard mode. At the main menu, press the Image control option, then press TGC theoption. Last, press the Standard option. Once these steps are completed return to the main menu by pressing Escape until the main menu appears. TO enter a. b. C. d. ARIC phantom information on the tape menu screen, do the following: Press the fourth menu key to display the Setup menu. Press the first menu key to display Patient menu. Press the first menu key again. NAME becomes highlighted. Type in the phantom Serial number and the transducer serial number, separated by a space. Press the RETURN key. Press second menu key for Participant ID information. Type in the field center location and sonographer ID number. Press the RETURN key to return to the Patient menu. When all entries have been made, press the ESCAPE key twice to reach the MqinMenu. - PROTOCOL6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 as 8 The Doppler cursor can be removed by pressing the green DOP CURSOR key located on the Phase2 keyboard. This key may be toggledON o r OFF. Place Doppler cursor inthe middle section of the screen. To put the crosshair on the image to define the for landmark identification, do the following: a. b. C. d. e. The vertical center of the screen Press the third menu key to display the Calculate menu. Press the first menu key to display Distance menu. Press the first menu key again for "Distance plus". the cursor will , appear in the upper portion of the screen. Move the cursor to the vertical center position identified bythe doppler cursor, and make certain it is kept the in vertical center when it is moved during the performance check. The transducer power is activated, and the system is placed in the normal B-scan imaging mode. The transducer focus setting is placed in the 3.0 cm focus position (Far focus). Adjust video gain to 50% and adjust TGC settings for optimal imaging. sonographer enters the RECORD mode by turning off the pause switch on the NEC PC-VCR, and scans the phantom. Throuahout the scan, exert only minimal pressure on the phantom surface with the transducer. To obtain the images in this procedure the long dFmension of the white transducer plate is to parallel the long dimension of th-- phantom. The sonographer obtains a cross-sectional view of the most superficially ( 2 cm depth) located simulated vessels and then positions the larger ( 6 mm diameter) of the three vessels the in vertical center of the screen as confirmed by the cursor position. Toggle the Doppler cursor OFF. The crosshair should be contained well within the outline of the vessel, insuring that it does not obscure the reflections from the or far near walls (Figure 10). When a satisfactory image is seen on the screen, mark this point on the tape for Ultrasound the Reading Center. The sonographer moves the transducer toward the the headtable of in order to view the set of filaments ranging from 0.5 to 4 . 0 cm. These are also viewed in cross-section, making certain the transducer focus setting the is 3.0 in cm position. Using the crosshairas a guide, the filaments are lined up so that they are centered horizontally across the center the ofscreen (Figure 11). The cursor is positioned in the middle of the screen, taking to avoid care obscuring any of the filament reflections. The reflections of the deeper filaments will have gaps in them due to shadowing caused by the filaments superficial to them (Figure 11). Those gaps are used as an aid in liningup the filaments properly. When a satisfactory image is seen, the select footswitch to mark this image. This concludes the weekly instrument performance test on the RMI phantom. The water is carefully removed from the phantom, and the phantom is returned to its storage location in the manner described in Section 4.3. Each phantom tape is labeled according to the following format: - - PHANTOM F- 93 03 - 12 - 001 F = the fieldcentercode 93 = the year the tape is started 09 = the month the tape is started 12 = the month the tape is complete (left blank until tape is full) 001 = sequential number of each tape (begins with 001 at each field center) ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 9 This label should be placed on the videocassette. The video cassette box should alsobe labeled accordingly. At the end of each week, the cassetteis shipped to the Ultrasound Reading Center with the current shipment of B-mode tapes. A second tape is used to record the next week's scan(s) and a third tape for the week after. These three tapes will be rotated until they are full. Completed tapes willbe stored at the Ultrasound Reading Center, and another tape will be started at the field center when this occurs. 4.3.2 Additional Points While scanning following: the to Remember phantoms, the sonographer to look is for changes in the shape of simulated vessels (these should appear circular) the gain settings required to obtain adequate images, or the focal settings required to obtain images. If the sonographer notices changes in any of these conditions, he/she should do the following: Contact the Biosound technician authorizedto work with this instrument (Bob Nitsch 8001428-7378) and Contact the Ultrasound Coordinator at the Ultrasound Reading Center at (910)759-2137 and report the actionto be taken by the Biosound technician Note: Other Biosound personnel should not work on the instrument unless specifically authorized by Mr. Nitsch. If .r the phantom surface begins to cave in or pucker: Call the supplier to arrange service. Notify the Ultrasound Reading Center Coordinator immediately. Following any service call, the chief sonographer isto send a copy service reportto the URC Coordinator and/or Phantom reader. of the It is important to vary the location of the transducer within the prescribed areas on the phantom when doing the scans, i.e., position in the center, left Of center, right of center, in order to extend the life of the phantom. 4.4 486-SX Computer exception In general, no maintenance is required on the computer with the that, if there is one, the clock battery is replaced annually. In case of appropriate system problems, the field center data coordinator contacts the authorized repair facility. 4.5 any IBM-XT Computer except ion on the computer with the In general,no maintenance is required that, if there is one, the clock battery is replaced annually. In case of any system problems, the field center data coordinator contacts the appropriate authorized repair facility. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION3.0 01/95 10 4.6 Dinamap Automated Blood Pressure It is recommended that the Dinamap Model 1846 SX be calibrated every six months using calibration proceduresin the Dinamap instructionmanual. Copies of calibration reportsare to be forwarded to the Ultrasound Reading Center. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 11 SONOGRAPHER’S BOX STOP STUDY SCREEN SELECT 0 @ gF PREV. SCREEN FRONT PANEL TO NEXT SITE I TO COMPUTER AUDIO OUT FooTSWITCH TO SELECT FOOTSWITCH REAR PANEL Figure 1. Ultrasound Assessment Equipment: Sonographers’s ARIC PROTOCOL 6a. Ultrasound Scanning P r o c e d u r e s - Visit BOX 3 VERSION 3 . 0 0 1 / 9 5 12 BIOSOUND PHASE 2 - REAR PANEL SHOWING VCR OUTPUTTO COMPUTER 1 I RS-232C/ CASSETTE RECORDER UL LABEL ANT IN I L OUTPUT TO + TRACKER #'(RF IN) l +lRFOUT@ OUTPUT TO TRACKER C2 (TRIG IN) 0' BIOSOUND PHASE 2 REAR PANEL CONNECTIONS TRIG VCR Figure 2. ARIC Ultrasound Assessment Equipment: Biosound Phase 2 VCR PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 13 REAR OF BIOSOUND PHASE 2 - VIDEO PRINTER MODE 1 MODE 2 Dl P SWITCHES v TO VIDEO PRINTER f" CON NE CTl ON PHASE2REAR I D E 0 - R H H-PO AC LINE E M 0 T 0 E I G POWER SUPPLY FUSE SPECIFICATION MONITOR Figure 3 . UltrasoundAssessment Equipment: ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n g MONITOR BiosoundPhase Procedures - 2 Printer V i s i t 3 VERSION 3.0 01/95 14 MAP u l l y OPLRATION (rn) PULSE OTEU 1 I 8I 9 Figure 4. 2 I 7 Ultrasound Assessment Equipment: Monitor DIN- ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - V i s i t 3 VERSION 3.0 01/95 15 - Computer PC 486 F a c i n g Rear P a n e l 1 Inpu.ts from S o n o g r a p h e r ' s Box (Red l i n e upward) <z> power I n p u t s ' f r o m P h a s e I1 (Red l i n e on l e f t ) IInputs.fromDinamap Data I n t e r f a c e Figure 5. 0- Ultrasound Assessment Equipment: U I n p u t sf r o m ComputerKeyboard Computer ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - - PC 486 Visit 3 VERSION 3.0 01/95 16 TOWER COMPUTER -PC, 486 FACING REAR PANEL -.-- ._."" _ ". " " . rnou roe Box nco maw ! I t s ON Figure 6. Ultrasound Assessment Equipment: Tower P C 4 8 6 ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 17 Vent not y e d \ (0 p ul \ [I ‘ 1 ’ 1 1 not used Figure 7. e to 0th r computer I po’wer cable rnonit/or cable Dhamap cable keyboard Ultrasound Assessment Equipment: Computer IBM-XT ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 18 CABLING C O N N E a I O N S REFERENCE VTR LEFT AUDIO OUT WITH AN LEFT AUDIO IN VTR RIGHX AUDIO WITH AN RIGHT AUDIO IN OUT VTR RIGHT AUDIO IN WITH AN RIGHT AUDIO OUT VTR VIDEO OUT WITH A N VIDEO VIR VIDEO IN WITH AN VIDEO OUT NEC VCR POWER CONNECTION WITH POWER SUPPLY IN NEC VCR A N VIDEO PRINTER PRINTER VI0 IN NUMBER 8A NUMBER 8B AC LINE VIDEO PRINTER Figure 8. Ultrasound Assessment Equipment.: Cabling Connections Reference AFtIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 19 Figure 9 . Phantom Placement 20 Figure 10. Cross S e c t i o n or Transverse View of 6 mm Phantom Target Figure 11. Phantom Filament Images ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - V i s i t 3 VERSION 3.0 01/95 21 5. DAILY PRELIMINARIES 5.1 Equipment The equipment in the ultrasound area is turned on and warmed up for a minimum of 30 minutes beforeany studies begin. The equipment is to be turned on in the followina order: 1. Biosound Phase 2 2. NEC VCR 3. Dinamap 4. Arterial Wall Tracker 5. Strip Chart Recorder 6. Oscilloscope 7. IBM-XT Computer 8. 486 5.2 Computer Biosouad Phase 2 Setup As the unit powers up, the two monitors on the begin unit to will set up their menus. The monitor on the right displays the main menu. The menu displays instructions €or the operator to finish the boot-up procedure. When the "Press any key" message appears on the screen, press the letter "D" on the Phase 2 keyboard and wait for Main Menu to appear on the right monitor of the Phase2 , at the bottom of screen. If any key other than"D" is pressed the unit is put into a. "time out"mode. For study purposes a time out mode is not appropriate. Therefore, the operator should press"D". This will put the unit in a continuous mode of operation. Check the VCR display screen for VCR setting. Check the channel display for setting L. If the "L" is not displayed, press the up and down arrow keys on the VCR keyboard labeled "Channel" until it does appear. - Visit 3 VERSION 3.0 01/95 ARIC PROTOCOL 6a. Ultrasound Scanning Procedures 22 The VCR s e t t i n g s s h o u l d P a n e l Setti n s s : be a s f o l l o w s : Record L e v e l L = 5 R = a t l e a s t 5 o r more, a d j u s t t o s o n o g r a p h e rp r e f e r e n c e e x c e e d Red l e v e l o n Remote C o n t r o l = TapeRemain ON 1 2 - not to scale d i s p l a y same a s Remote R/C S e t t i n g = T120 Edit = off L i n e I N = VIDEO S-VHS = ON K e y b o a r dS e t t i n s s : TV/CATV = A I R ( d i s p l a y e d t o t h e r i g h to fc o u n t e r ) Stereo/ L / R / Normal = L = R D i s p l a y e du n d e ra u d i o scale Select PROBE 1, l o c a t e d o nt h eB i o s o u n dP h a s e u p f o r 30 m i n u t e s . . ThePhase 2 b o o t - u pp r o c e d u r e 2 keyboard..Theprobemust warm i s now complete. In order t o obtainthehighestqualityimages €or t h i s e q u i p m e n t , t h e B i o s o u n d 2 mustbe i n t h e LUT LN mode. Check manual d i r e c t s t h a t t h e B i o s o u n d P h a s e f o r t h e "LUT LN" s e t t i n g o n t h e t h i r d l i n e o f t h e r i g h t P h a s e 2 m o n i t o r .I f t h e b l u e IMAGE PROCESS keyand select t h e "LUT LN" i s n o t p r e s e n t , p r e s s "LINEAR". T h i s w i l l be d i s p l a y e d i n t h e u p p e r r i g h t p o r t i o n o f t h e screen. P r e s s t h e f i r s t menu k e y ,l o c a t e do n t h e Phase 2 keyboard, t o make s e l e c t i o n f o r "LUT LN". A f t e ra c q u i r i n g "LUT LN", p r e s st h e ESCAPE key. (NOTE: Menu k e y s are t h e f i v e b l a c k k e y s l o c a t e d at thetopofthePhase 2 keyboard.) Check t h e image o r i e n t a t i o n . I t must be i n s t a n d a r d mode. A t t h em a i n menu, press t h e TGC o p t i o n .L a s t , press t h e p r e s s t h e Image c o n t r o l o p t i o n , t h e n Once t h e s e s t e p s a r e c o m p l e t e d r e t u r n t o t h e main menu b y S t a n d a r do p t i o n . p r e s s i n g Escape u n t i l t h e m a i n menu a p p e a r s . ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n gP r o c e d u r e s - Visit 3 VERSION 3.0 01/95 23 To a. b. C. de enter participant information on the menu screen, do thefollowing: tape Press the 4th menu key to display the Setup menu. Press the first menu key to display Patient menu. Press the first menu key again. Name becomes highlighted. Type in participant's last name, followed by first and middle initials. Press the ESCAPEkey or the RETURN key. Press the second menu key for Participant ID information. Type in the field center identification code, followed by the participant's ID number. Example: F123456. Press the ESCAPE key or the RETURN key t o Seturn t o the Patient menu. When finished, press the ESCAPE key twice t o reach the main Menu. The Doppler cursor can be removed by pressing the green DOP on the Phase2 keyboard. This key may be toggled ON or OFF. CURSOR key located The Phase 2 is now set up for scanning. 5.3 Supplies The supplies to be used for each day are checked. following: a. b. C. d. e. f. This includes the - Video cassettes sVHS cassettes for the NEC PC-VCR 3 112" diskette for each for each video cassette Participant ID Labels Identification labels are applied to the video cassettes and the diskettesused to store participant information. Aquasonic gel Paper wipes 5 114" diskette for each video cassette to be used with IBM-XT - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 24 6. ARTERIAL SITES AND ANATOMIC STRUCTURES TO BE EXAMINED Ultrasonic imaging methods are used to obtain a non-invasive quantitative measure of early atherosclerotic disease. The carotid arteries which the are principal suppliersof blood to the brain are a common location for early disease, primarily within or in close proximity to the bifurcation. These arteries, generally located within a few centimetersof the skin surface, are well suitedto examination with high resolution ultrasonic imaging methods. The ultrasound examination concentrates around the segment the inrightand left carotid artery known as the carotid bifurcation (See 12). Figure Ultrasound examination is attempted 10 at defined siteson the nearand far walls within thisarea. FoAlowing a preliminary transverse scan,the sitesto be examined are longitudinally visualized in the middle third the B-mode of image screen with the wall boundaries oriented vertically as nearly as possible on the screen. 6.1 Priority for Boundary Visualization In most instances, it is not possible to simultaneously obtain high quality longitudinal images of both the near and far wall boundaries of the arterial segment being examined in the same image frame. This condition.results primarily from the highly specular nature of the ultrasonic reflections from the blood-intima boundaries and the general deviation the ofarterial geometry from a cylindrical shape. Consequently, priorities must be placed on which arterial wall boundaries should be visualized with the others being visualized if possible but with potentially lesser quality. The two boundaries to be visualized first are the media-adventitia boundary on the far wall and the adventitia-media boundary on the near wall. This permits the outer boundaries of the media to be identified an andestimateof the arterial diameter to be measured. The third boundary,the far (deeper) wall blood-intima, then is visualized while maintaining good images the of first two boundaries. This permitsa measurement of the far wall intimal-medial thickness. Fourth, if. possible without losing this third boundary, the intima-blood boundarv on the near (shallower) wall is visualized. An image of the common carotid artery in which all four boundaries are visualized is shown in Figure 13. This sequence of priorities is used when imaging any segment of the carotid arteries with the exception of special views at the bifurcation 6.2. and the internal carotid. These are discussed in Section 6.2 The Carotid Arteries 6.2.1 Anatomical References The arterial segments defined for ultrasonic examination are referenced to certain anatomical landmarks which are normally identifiable within the carotid system. One is the tip of the flow divider which defines the position along the vessel where the internal carotid artery and external carotid artery begin. A second, but less clearly delineated, is the location where the common carotid artery begins to widen into the carotid bifurcation. These landmarks are illustrated in Figure 12. In order to image defined segments referenced to these landmarks, longitudinal images are required. During each image sequence the cursor on the Biosound image screen is placed the at vertical level of the appropriate landmark for use the reading in of the Bmode images at the Ultrasound Reading Center. ARIC - PROTOCOL6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 25 6.2.2 O p t i m aIln t e r r o g a t i oA n ngle permits c l e a r i d e n t i f i c a t i o n The optimal u l t r a s o n i c i n t e r r o g a t i o n a n g l e w h i c h oftheanatomicalreferencesonthe B-mode i m a g e s d e p e n d s u p o n s p e c i f i c a n a t o m i c a lf e a t u r e so f t h e p a r t i c i p a n t .T h i sd e p e n d e n c eo fi n t e r r o g a t i o n care be g i v e n d u r i n g angleontheindividualparticipantrequiresthatgreat t h e p r e l i m i n a r ye x a m i n a t i o n t o i d e n t i f yt h i sa n g l e . I t d e p e n d su p o nb o t ht h e ultrasoundtransducerpositionand t h e orientation of the head of t h e participant . I ft h ep r o x i m a ls e g m e n t so ft h ei n t e r n a la n de x t e r n a l carotid arteries l i e i n a common p l a n e , it s h o u l d be possible t o i n t e r r o g a t e t h e b i f u r c a t i o n f r o m a n a “Y” a p p e a r a n c e . T h i s i s a n g l ew h i c hp r o v i d e sa ni m a g ec h a r a c t e r i z e db y i l l u s t r a t e di nF i g u r e 14. From t h i s a n g l e , t h e l o c a t i o n o f t h e two a n a t o m i c a l references,thetipoftheflowdividerandtheinitial common c a r o t i d w i d e n i n g i n t o t h eb i f u r c a t i o n ,c a n be s e e n .I n some i n d i v i d u a l s , it is o f t e n a pronounced d i f f i c u l t to sharply define t h e origin of the bifurcation if w i d e n i n g does n o t o c c u r , b u t it i s most l i k e l y t o be v i s i b l e f r o m t h i s a n g l e . I f t h e p r o x i m a ls e g m e n t s of t h e i n t e r n a l a n d e x t e r n a l c a r o t i d a r t e r i e s do n o t l i e i n a common p l a n e , it may be i m p o s s i b l e f o r t h e s o n o g r a p h e r t o o b t a i n t h e c h a r a c t e r i s t i c ”Y” a p p e a r a n c e a t t h e b i f u r c a t i o n . E i t h e r o n e o r t h e o t h e r of t h eb r a n c h e sc a n be imaged a t a g i v e n i n t e r r o g a t i o n a n g l e b u t n o t b o t h . I n many cases, r e p o s i t i o n i n g o f t h e h e a d o f t h e p a r t i c i p a n t (see S e c t i o n s 8.1. and 8.2) may p e r m i t t h e t w o arteries t o more c l o s e l y a p p r o a c h a common p l a n e . O f t e n c a r e f u l a t t e n t i o n t o t h i s p o s i t i o n a n d small p a r t i c i p a n t h e a d a n g l e c h a n g e s w i l l p e r m i t t h e “Y” t o be v i s u a l i z e d . A p r e l i m i n a r y t r a n s v e r s e s c a n as described i n S e c t i o n 8.1.3 p e r m i t s the o p t i m a l i n t e r r o g a t i o n a n g l e t o be closelyapproximatedeveninthe more d i f f i c u l t a n a t o m i c a l c o n f i g u r a t i o n s . 6.2.3 The Common Carotid A r t e r y I m a g e so ft h e common c a r o t i d a r t e r y a r e o b t a i n e d a t t h e o p t i m a l i n t e r r o g a t i o n angle:. They are r e f e r e n c e d t o t h e o r i g i n o f t h e b i f u r c a t i o n w h e r e t h e common c a r o t i d b e g i n s to widen. T h e s e g m e n tl o c a t e d 10 mm p r o x i m a l t o t h i sl a n d m a r k i s t h e f o c u s o f a t t e n t i o n . B o t h t h e n e a rw a l la n df a r wall i n t e r f a c e s are attempted i n t h i s view. 6.2.4 The C a r o t i d B i f u r c a t i o n t h e c a r o t i d b i f u r c a t i o n e x t e n d i n g 10 mm p r o x i m a l t o t h e t i p Of Thesegmentof i s imaged a t t h e o p t i m a l a n g l e . I n some p a r t i c i p a n t s t h i s t h ef l o wd i v i d e r place t h e c u r s o r a t may e x t e n d i n t o t h e common c a r o t i d . Thesonographermust thelevelofthetipofthe flow divider. Images a r e t h e n a c q u i r e d a t t h i s i n t e r r o g a t i o n a n g l e t a k i n g great c a r e t o use the priority sequence of boundary visualizationdescribedinSection 6.1. 6.2.5 The I n t e r n a cl a r o t i dA r t e r y w a l l e x t e n d i n g 10 mm d i s t a l Thesegmentoftheinternalcarotidarteryfar from t h e t i p o f t h e flow d i v i d e r i s now imaged a t t h e o p t i m a l a n g l e . Images are a c q u i r e d o f t h i s s e g m e n t o n c e a g a i n m a r k i n g t h e t i p of the flow divider as t h e a n a t o m i c a ll a n d m a r k . I t is i m p o r t a n t t o c a r e f u l l yd i s t i n g u i s hb e t w e e n the i n t e r n a la n de x t e r n a lc a r o t i d a r t e r i e s u s i n g t w o c r i t e r i a : 1. n o r m a l l y t h e i n t e r n a lh a s a s i g n i f i c a n t l yl a r g e r diameter t h a nt h ee x t e r n a l ; 2. t h e blood flow v e l o c i t y p a t t e r n i n t h e t w o vessels as d e t e r m i n e d w i t h D o p p l e r u l t r a s o u n d ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n g Procedures - V i s i t 3 VERSION 3.0 01/95 26 is d i s t i n c t l yd i f f e r e n t . Used t o g e t h e r ,t h e s e t w o c o n s i d e r a t i o n sp e r m i tt h e i n t e r n a l c a r o t i d a r t e r y t o be i d e n t i f i e d w i t h a h i g h d e g r e e of c o n f i d e n c e . it i s n e c e s s a r y t o d i s t i n g u i s h D u r i n gt h ep r e l i m i n a r ys c a n n i n gp r o c e d u r e c l e a r l yb e t w e e ni n t e r n a la n de x t e r n a l c a r o t i d arteries. A l t h o u g ht r i b u t a r i e s ,originating from the external carotid artery may o c c a s i o n a l l y be v i e w e d w i t h most B-mode u l t r a s o u n d t o h e l p i n t h i s d i f f e r e n t i a t i o n , D o p p l e r u l t r a s o u n d i n cases i s more e f f i c i e n t a n d s p e c i f i c f o r t h i ss e p a r a t i o n .T h em e t h o da n d criteria f o r t h i s i d e n t i f i c a t i o n a r e a s follows: of t h e c a r o t i d b i f u r c a t i o n w h e r e t h e common c a r o t i d a r t e r y d i v i d e s .I n some i n s t a n c e s t h e best a n a t o m i c a la n g l e w i l l show t h e f l o w d i v i d e r a s well a s t h e p r o x i m a l i n t e r n a l a n d e x t e r n a l carotid arteries. In the remaining cases t h e flowdividerandonlyonevesselcan be s e e n f r o m a s i n g l ea n g l e .I nt h o s ei n s t a n c e st h eo t h e ra r t e r yc a n be v i s u a l i z e d b y g e n t l y r o c k i n g t h e u l t r a s o u n d probe b a c k a n d f o r t h i n a n g l e or p o s i t i o n or b o t h . Doppler i s u s e d t o d i f f e r e n t i a t e i n t e r n a l a n d e x t e r n a l c a r o t i d arteries i n t h e s ei n s t a n c e s . To o b t a i n a Doppler s a m p l eo fe a c ha r t e r y ,t h eD o p p l e r samplevolume i s p l a c e di n t ot h eb r a n c hf a r t h e s tf r o ms k i ns u r f a c e .T h e aonographer observes the tracing on the TV m o n i t o r a n d l i s t e n s t o theDoppler signal. If t h e u l t r a s o u n dp r o b e is i nt h ei n t e r n a l c a r o t i d a r t e r y ,t h ef l o w p a t t e r n w i l l b e t h a t of a l o w - r e s i s t a n c e bed. T h i s s i g n a l h a s a r a p i d u p s t r o k ea n d a q u a s i - s t e a d y f l o w t h r o u g hs y s t o l ea n dd i a s t o l e . The flow c o n t i n u e s t h r o u g h o u t t h e cardiac c y c l e a n d b e g i n s t o increaseagain a t t h e nextsystole. A B-mode image i s o b t a i n e d The f l o w p a t t e r n i s g r a p h i c a l l yd i s p l a y e dn e a r t h e z e r ob a s e l i n e .F l o w d i r e c t e d toward t h e head and awayfrom t h e heart throughout t h e c y c l e is represented a s a t r a c i n ga b o v et h e b a s e l i n e i n F i g u r e 15. I f t h e D o p p l e r s i g n a l does n o t c o r r e s p o n d t o t h e e x p e c t e d p a t t e r n , t h e c u r s o r is p l a c e d w i t h i n t h e o t h e r b r a n c h of t h e common c a r o t i d a r t e r y . The e x t e r n a l c a r o t i d a r t e r y is usually nearer the skin surface when v i e w e d f r o m a n a n t e r i o r a n g l e and is a h i g h - r e s i s t a n c ev e s s e l .T h ec h a r a c t e r i s t i c so ft h eD o p p l e rs i g n a li n t h i s v e s s e l are a forward f l o w w i t h a s h a r p u p s t r o k e a n d sometimes a r e v e r s a l of t h ef l o w a t d i a s t o l e ( m u l t i p h a s i c ) . The h a l l m a r k of a h i g h - r e s i s t a n c e a r t e r y i s c e s s a t i o n o f flow b e f o r e t h e o n s e t o f t h e n e x t s y s t o l e as defined i n F i g u r e 16. Abnormal f l o w i s d e m o n s t r a t e d b y t u r b u l e n c e w i t h i n t h e l u m e n a n d d i s r u p t i o n of normalflow. T h i s i s i d e n t i f i e di nt h eD o p p l e rs i g n a lb yb r o a d e n i n gt h e Doppler s p e c t r u m .S e v e r en a r r o w i n g of t h e a r t e r y lumen i s i d e n t i f i e d b y a n i n c r e a s ei nt h ee x p e c t e dp e a ks y s t o l i cf r e q u e n c y .I fo c c l u s i o n is p r e s e n t and i n t e r n a l t h e r e w i l l be no D o p p l e r s i g n a l , i n w h i c h c a s e t h e e x t e r n a l c a r o t i d a r t e r i e s c a n be d e f i n e d b y t h e e x t e r n a l b e i n g more a n t e r i o r t o t h e i n t e r n a la n a t o m i c a l l y . I f f l o w i s s a m p l e df r o mt h e common c a r o t i d a r t e r y , small r e v e r s a l of f l o w a n d a t h e r e w i l l be a r a p i d s y s t o l i c u p - s t r o k e w i t h q u a s i - s t e a d yf l o wt h r o u g h o u td i a s t o l e .T h i s i s a c o m b i n a t i o no fi n t e r n a la n d more e x t e r n a lc a r o t i df l o wp a t t e r n s ,a s shown i n F i g u r e 17. B e c a u s eo ft h e v a r i e dp o s i t i o n i n ga n dg e o m e t r y of t h e i n t e r n a l c a r o t i d , t h e s e q u e n c e o f p r i o r i t i e s t o be u s e d when imaging t h i s segment i s m o d i f i e d f r o m t h a t u s e d i n The t w o f a r w a l lb o u n d a r i e ss h o u l dr e c e i v e t h e common a n d b i f u r c a t i o n . h i g h e s t p r i o r i t y , t h e n e a r wall a d v e n t i t i a - m e d i a i n t e r f a c e n e x t p r i o r i t y a n d f i n a l l y t h e n e a rw a l li n t i m a - b l o o db o u n d a r y . 6.2.6 I n d e p e n d e n t V i e w s of t h e Far a n d Near B i f u r c a t i o n Walls ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 27 6.2.6.1 Far w a l l Afterimagingthefar wall of t h e i n t e r n a l , t h e carotid b i f u r c a t i o n a t t h e optimal a n g l e i s i m a g e da g a i n . T h e u l t r a s o u n dt r a n s d u c e r is t i l t e d a l o n g t h e a r t e r i a l a x i s i n s u c h a manner t h a t t h e f a r wall o f t h e b i f u r c a t i o n becomes v e r t i c a l i n t h e c e n t e r of t h e d i s p l a ys c r e e n . The q u a l i t y of t h e n e a r w a l l e c h o e a w i l l d e t e r i o r a t e . A t t h i s time, small c h a n g e si nt r a n s d u c e ra n g l e are made eo i m a g e t h e f a r w a l l b l o o d - i n t i m a a n d m e d i a - a d v e n t i t i a i n t e r f a c e s . A f t e r t h e f a r wall image i s o b t a i n e d , t h e t r a n s d u c e r i s rotated back t o o b t a i n t h e c a r o t i d b i f u r c a t i o n optimal a n g l e i m a g e a g a i n . 6.2.6.2 Near w a l l t h e a x i s o f t h e a r t e r y so t h a t t h e n e a r wall o f t h e b i f u r c a t i o n i s now o r i e n t e d v e r t i c a l l y i n t h e c e n t e r o f t h e d i s p l a y w i l l deteriorate. Small changes s c r e e n .T h eq u a l i t yo ft h ef a rw a l le c h o e s i n t r a n s d u c e r a n g l e a r e made t o image t h e n e a r w a l l a d v e n t i t i a - m e d i a a n d i n t i m a - b l o o di n t e r f a c e s . The t r a n s d u c e r i s r o t a t e d a l o n g 6.3 6.3.1 Cursor P l a c e m e n t by S i t e and S i d e U l t r a s o u nMd o n i t o r be marked i n b l a c k on t h e i m a g e s c r e e n o f t h e Horizontal parallel lines should u l t r a s o u n d B-mode imagemonitor. T h e s e l i n e s s e r v e t o delimit t h e optimal i m a g i n gr e g i o nw h i c h i s t h i sm i d d l ep o r t i o n of t h ei m a g e area. T h e s e l i n e s are referred t o a s t h e u p p e ra n dl o w e ri m a g i n gl i n e s .T h e two h o r i z o n t a l 18 a r e located where t h e black l i n e s s h o u l d be markedon l i n e s shownonFigure are t o b e p o s i t i o n e d 3 / 4 i n c h i n s i d e t h e top t h ei m a g es c r e e n .T h e s el i n e s a n db o t t o mp o r t i o n of t h e a c t i v e B-mode imaging area. The c r o s s h a i r (+) i s placed a t t h e l e v e l o f o n e of these l i n e s t o mark t h e l o c a t i o n o f t h e s i t e beingimaged.Theplacementof the a n a t o m i c a ll a n d m a r kf o rt h es p e c i f i c c r o s s h a i r i s i l l u s t r a t e d f o r a l l s i t e s i n F i g u r e 19. ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 28 6.3.2 Common CarotidCrosshair Placement i s o r i e n t e d so t h a t t h e a r t e r i a l walls appear The common c a r o t i d a r t e r y i m a g e v e r t i c a l l y o n t h e m o n i t o rs c r e e n .T h eu l t r a s o u n dt r a n s d u c e r i s moved so t h a t theupperimaginglinemarkedontheBiosoundscreenpassesthroughtheorigin a r t e r i a l walls. T h ec r o s s h a i r is o ft h eb i f u r c a t i o no nb o t hn e a ra n df a r p l a c e do nt h eu p p e ri m a g i n gl i n e ,a p p r o x i m a t e l yi nt h e center of t h e lumen. lower i m a g i n g l i n e s Theoptimum u l t r a s o u n d i m a g e a p p e a r s b e t w e e n t h e u p p e r a n d F o rt h el e f t common c a r o t i d a r t e r y , t h e ( d e s c r i b e d i n s e c t i o n 6.3.1). u l t r a s o u n d t r a n s d u c e r i s moved so t h a t t h e lower i m a g i n g l i n e passes t h r o u g h a r t e r i a l walls. The t h eo r i g i no ft h eb i f u r c a t i o no nb o t hn e a ra n df a r lower i m a g i n g l i n e , a p p r o x i m a t e l y i n t h e c e n t e r of crosshair is placedonthe t h e l u m e n .T h eo p t i m u mu l t r a s o u n di m a g ea p p e a r sb e t w e e nt h e lower a n du p p e r i m a g i n gl i n e s . 6-3.3 B i f u r c a t i o n Area C r o s s h a i Pr l a c e m e n t The landmark f o r a l l i m a g e s i n t h e b i f u r c a t i o n a r e a i s t h e t i p o f t h e f l o w d i v i d e r .I n some v i e w s , t h e t i p o f t h e flow d i v i d e r may d i s a p p e a r , b u t t h e crosshairshouldindicate i t s l o c a t i o no nt h em o n i t o rs c r e e n . Fortheright side, t h e t i p of t h e f l o w d i v i d e r i s placed o n t h e u p p e ri m a g i n g l i n e . The c r o s s h a i r i s placed o n t h e u p p e r i m a g i n g l i n e a t t h e t i p of t h e f l o wd i v i d e r .T h ec r o s s h a i r i s placed w i t h i nt h el u m e n , t o a s s u r e t h a t it w i l l b e well c l e a r of a l l measurement areas. T h eo p t i m u mu l t r a s o u n d image a p p e a r sb e t w e e nt h eu p p e ra n d lower imaging l i n e s . I n t h e t w o v i e w s of t h e b i f u r c a t i o n when o n l y t h e r i g h t f a r w a l l o r n e a r w a l l i s imaged, t h e t i p of t h e f l o w d i v i d e r i s p l a c e d o n t h e u p p e r i m a g i n g l i n e . T h e c r o s s h a i r i s a l s op l a c e do nt h eu p p e ri m a g i n gl i n e .T h eu l t r a s o u n d wall image i s o p t i m i z e d .T h e t r a n s d u c e r i s m a n i p u l a t e du n t i l t h e f a r o r n e a r c r o s s h a i r i s t h e n moved t o a p o s i t i o n a l o n g t h e u p p e r i m a g i n g l i n e n e a r the wall i n t e r f a c e sb e i n gi m a g e d .T h ec r o s s h a i rs h o u l dn o ti n t e r f e r ew i t ht h e wallinterfacesbeing 'imaged, b u t r e m a i n i n t h e lumen area. F o r t h e l e f t side, t h e t i p o f t h e f l o w d i v i d e r is p l a c e d o n t h e lower i m a g i n g crosshair i s p l a c e d a t t h e t i p o f t h e f l o w d i v i d e r o n t h e lower l i n e .T h e i m a g i n gl i n e .T h eo p t i m u mu l t r a s o u n di m a g ea p p e a r sb e t w e e nt h e lower a n d t h e u p p e ri m a g i n gl i n e s . I n t h e t w o viewsofthebifurcation, when o n l y t h e l e f t f a r wall o r near wall is imaged, t h e t i p o f t h e f l o w d i v i d e r is p l a c e d o n t h e lower i m a g i n g l i n e . The u l t r a s o u n d t r a n s d u c e r i s m a n i p u l a t e d u n t i l t h e f a r o r n e a r wall image i s o p t i m i z e d .T h ec r o s s h a i r i s t h e n moved t o a p o s i t i o n along t h e lower i m a g i n g l i n en e a rt h ew a l li n t e r f a c e sb e i n gi m a g e d . The crosshair s h o u l dn o t the i n t e r f e r e w i t h t h e wall i n t e r f a c e sb e i n gi m a g e d ,b u ts h o u l dr e m a i ni n lumen area. ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 29 6.3.4 Internal Carotid Crosshair Placement The landmark for the internal carotid artery is the tipof the flow divider. Primarily, the far wall of the internal carotid is imaged. For the right side, the tip of the flow divider is placed on the lower imaging line..': The crosshair is placed on thelower imaging line, approximately in the center of the lumen. The optimum ultrasound image appears between the lower and upper imaging lines. For the left side, the tipof the flow divider is placed on the upper imaging line. The crosshair is placed on the upperimaging line, approximately in the center of the lumen. The optimum ultrasound image appears between the upper and lower imaging lines. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 30 Landmarks InternalIExternal Segment Tip o fF l o wD i v i d e r Bifurcation Segment /- -O r i g i n Common Car0 t id Segment of B i f u r c a t i o n I Figure 12. Schematic of Carotid Artery Segments Interrogated ARIC PROTOCOL 6a. U l t r a s o u n d S c a n n i n g P r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 31 Right Common Carotid Artery -3 I 2 1. Periadeventitial - adventitialnearwall interface 2. Adventitial - medialnearwall interface 3. Intimal - lumen near wall interface 4. Lumen - intimal far wall interface 5. Medial - adventitial far wall interface 6. Adventitial -.Deriadventitial farwall interface Figure 13 Common Carotid Artery (all four boundaries visualized) ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n g Procedures - V i s i t 3 VERSION 3 . 0 01/95 32 Right Carotid Bifurcation 1 6 \ 1. Periadeventitial - adventitial near wall interface 2. Adventitial - medialnearwall interface 3. Intimal - lumennearwallinterface 4. Lumen - intimal far wall interface 5. Medial - adventitial far wall interface 6. Adventitial - periadventitial far wall interface Figure 1 4 . The B i f u r c a t i o n ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 33 Internal Carotid Artery ARIC. PROTOC-L 6a. U l t r a s o u n d . Scanning P r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 Proximal Common Carotid Artery 34 Ti me Figure 1 7 . D o p p l e rt r a c i n g : Flow Patterns Combination of I n t e r n a l and ExternalCarotid v ’ . Figure 1 8 . (Upper) - (Lower) BiosoundScreenCalibrationProcedure ARIC PROTOCOL 6a. UltrasoundScanningProcedures - Visit 3 VERSION 3.0 01/95 35 L e f t Side Right Side Common Optimal Angle Bifurcation Internal Bifurcation Far Wall Bifurcation Near Mal1 Figure 19. Image A s Seen On BiosoundMonitor: ARIC PROTOCOL 6a. UltrasoundScanningProcedures Proper Cursor Placement - V i s i t 3 VERSION 3 . 0 01/95 36 7. PARTICIPANT PRELIMINARIES t o r e f r a i nf r o ms m o k i n g ,' v i g o r o u s The p a r t i c i p a n t w i l l h a v eb e e na s k e d e x e r c i s e ,a n dd r i n k i n gc o f f e e , t e a and s o f t d r i n k s c o n t a i n i n g c a f f e i n e d u r i n g thenightprecedingandthedayoftheultrasoundexamination,sincethese may alter h e a r t rate and/orbloodpressure. 7.1 P a r t i c i p a nO t rientation t o Ultrasound Examination The p a r t i c i p a n t i s p o s i t i o n e d o n t h e e x m i n a t i o n t a l b e i n a s u p i n e p o s i t i o n . terms t h e e x a m i n a t i o n t o be done. A T h es o n o g r a p h e rd e s c r i b e si ng e n e r a l s u g g e s t e ds t a t e m e n tf o l l o w s : " U l t r a s o u n d i s a new p a i n l e s s a n d l o w - r i s k m e t h o d t o e x a m i n e arteries u s i n g a r e a b l e t o 'see' a r t e r i e s u n d e r s o u n dw a v e sw h i c hy o uc a n n o th e a rb u tw h i c h y o u rs k i n .B e f o r et h eu l t r a s o u n d exam b e g i n s , a t h i n g e l w i l l b e applied t o t h es k i n ,a n d a n i n s t r u m e n t w i l l b e placed on it. T h i sp r o c e d u r e w i l l be u s e d t o look a t t h e arteries o n b o t h s i d e s o f y o u r n e c k . D u r i n g t h e e x a m i n a t i o n , you w i l l h e a r t h e n o i s e a n d f e e l t h e v i b r a t i o n s of a small motor t h a t i s located w i t h i n t h e i n s t r u m e n t . O c c a s i o n a l l y you w i l l a l s o h e a r t h e a m p l i f i e d arteries. Theequipment w i l l a l s o record s o u n do f blood f l o w i n gt h r o u g hy o u r my v o i c e a s I name t h e p a r t s of t h e a r t e r i e s I s c a n . T h e complete u l t r a s o u n d or e x a m i n a t i o ns h o u l d be c o m p l e t e dw i t h i nf o r t y - f i v em i n u t e s .S i n c et a l k i n g s w a l l o w i n gc a nc a u s e t h e a r t e r i e s t o move o u t o f f o c u s a n d c a u s e t h i s p r o c e d u r e t o t a k el o n g e r ,y o u rc o o p e r a t i o nw o u l db e appreciated." Duringthisdiscussion,thesonographershould remember t h a t t h e e x a m i n a t i o n t o be d o n e 2 not d i a g n o s t i c i n n a t u r e , a n d t h a t a l l q u e s t i o n s asked by t h e p a r t i c i p a n t t h a t r e l a t e t o t h e p r e s e n c e o r a b s e n c e of a r t e r i a l d i s e a s e s h o u l d be referred to the medical director of the Field Center or t o h i s o n - s i t e r e p r e s e n t a t i v e .I n f o r m a t i o n t o be g i v e n t o t h e p a r t i c i p a n t o r h i s / h e r p h y s i c i a n is d e s c r i b e di nM a n u a l 2. 7.2 P a r t i c i p a n t Apparel T h eu l t r a s o u n dc o m p o n e n t of t h i s e x a m i n a t i o n r e q u i r e s e a s y access t o t h e s k i n o v e r l y i n g a r t e r i e s i nt h en e c k .P a r t i c i p a n t s wear loose f i t t i n g a p p a r e l p r o v i d e db y each f i e l d c e n t e r . J e w e l r y p r e s e n t o n t h e h e a da n dn e c k , i n c l u d i n g gold c h a i n s ,n e c k l a c e sa n d e a r r i n g s , i s removed p r i o r t o s c a n n i n g . 7.3 S t uPdrye l i m i n a r i e s 7.3.1 IBM-XT Computer The order i n w h i c h t h e blood pressure equipment is t u r n e d o n is c r i t i c a l t o t h es u c c e s s f u lf u n c t i o n i n g of t h ec o m p u t e rs y s t e m .T h eD i n a m a p is f i r s t t u r n e d on. I t i s e s s e n t i a l t h a t t h e Dinamap be i n Manual Mode a t a l l times. The IBM XT computer i s t h e n t u r n e d o n . A f t e r r e c e i v i n g replies t o p r o m p t s f o r d a t e and time c o r r e c t i o n , t h e IBM XT c o m p u t e rd i s p l a y s a c:\> p r o m p t .T h es o n o g r a p h e rt h e nt y p e s t h e command: GETBP on t h e IBM XT k e y b o a r da n dp r e s s e s t h e ENTER key. T h e c o m p u t e r prompts t h es o n o g r a p h e rf o r t h e p a r t i c i p a n t I D n u m b e rb yd i s p l a y i n gt h ef o l l o w i n g : ENTER PARTICIPANT I D : ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 0 1 / 9 5 37 The sonographer then enters the field center letter, followed the by participant ID number and presses ENTER. If a file for that participant already exists, the monitor will display the message: X12345 ALREADY EXISTS. YOU DO WISH TO OVERWRITE The computer program is not designed to save more one than fileon any participant. If the response entered by the sonographer "n", is the program automatically ends and returns the computer to the DOSprompt. If the response entered is '*y" or any other key except "n'*, the existing file will overwritten bythe file being created during this study. After the participant ID number has been accepted by both computer, the IBM XT computer monitor will display the message: Ready to take blood 7.3.2 sonographer be and pressure 486 Computer To initiate the ultrasound study flow program, type aricscan at the C:\> prompt and press ENTER. The date appears. If it is correct, press the ENTER the ENTER key. key. If the date is incorrect, type the correct date and press After pressing the ENTER key, the time appears. Verify or correct it as instructed aboveand-press the ENTER key. After pressing the ENTER key, ARIC STUDY appears, very quickly followed by the VERSION screen. Press the ENTER key. The computer screen will read "MOUNT TAPE AND MOUNT DISK B DRIVE. ENTER WHEN READY ." The ENTER key is pressed after completing each on field the screen. When the sonographer enters information on the screen, he/she may move to make back corrections by using the arrow keys on the keyboard. 7.4 Preliminary Questionnaire The operator completes the questionnaire as follows. The 486 computer screen will read: PUT TAPE IN THE PHASE 2 VCR and PUT ( 3 1/2") DISK IN DRIVE B e Follow the instructions, placing asVHS videotape cassette in the VCR, and a previously formatted 3 1/2" diskette. Press the ENTER key. After pressing the ENTER key, a WAIT setting upto record on the tape. message appears while the 2 is Phase Wait until the Demographic screen appears. One by one, the field requiring information to be supplied by the sonographer will be highlighted in yellow. For example, when the Patientis ID yellow, the sonographer would then type in the participant's ID number, followed by the ENTER key. Note that the field center (first) character is inserted automatically. Ifthe ID'S do not match, the sonographer should determine which computer the has wrongID. Then, exit the programon that computerand re-initiate the program,and enter theID correctly. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 38 Type the Visit Code, using two digits, and pressthe ENTERkey. Type the Sonographer ID, using three digits, and press the ENTER key. Verify the Cassette ID and press the ENTER key. The Cassette ID is automatically assigned by the computer program. Type participant's initials, last name, gender, race and date of birth,,pressing the ENTER key after each entry. When all fields have been filled in EVERYTHING CORRECT? appears on the lower portion of the screen. Answer N or Y. N signifies that an error was made in the demographic entries. Y signifies that everything is correct. Ifthe choice madeis Y, a wait screen appears while the VCRup sets to begin recording. (Do not press the ENTER key while the WAIT screen is visible.) If the choice is N, the demographics screen appears again, and incorrect entries are re-typed. (See above). After the last entry, VERIFY appears again. Type Y if all is correct: if not, type N and loop through this process once more. Information from this questionnaire is entered the intofield center computer. This information will be sent to the reading center on a diskette under the participant's .DEM file. 7.5 Blood Pressure 7.5.1 Applying the Blood Pressure Cuffto the Ankle If the date is an even number, place the cuff on the left ifankle; the date is an odd number, place the cuff on the right ankle. Apply the ankle blood pressure cuff to the lower extremity selected. (Socks or stocking have been removed, or moved below the ankle to keep participant's the foot and/or toes warm if the room iscool). Where practical, use the same cuff forthe ankle as for seated blood pressure. This information is found the in participant's chart. If the participant's ankle is very large and/or strongly tapered, a larger cuff may be necessary. While ankle blood pressures are obtained, the participant shoulda be in supine position without any pillows or support the underlegs, unless this causes discomfort. In most cases the participant will be comfortable in that position for the short time neededto take the ankle blood pressure. Ifa participant feels that a pillow is necessary, provide one and indicate on the log sheetthat a pillow was used during ankle blood pressure. Proper application of the appropriate cuff above the ankle of the selected leg is shown in Figure 20 or 21. Lay the cuff flat on the table (the surface marked "side to the patient" face up) with the ankle centered on the cuff. For the moment, disregard the "over the artery" marker. The lower edge of the cuff, from whichthe tubes extend, should be approximately2 to 2 1/2 inches above the medial malleolus. Following the contour the of lower leg, wrap the end of the cuff with the Velcro fastener over the ankle, as shown in Figure 20 or 21. Note that dependingon the degree of tapering this in area, the cuff corner willbe offset from parallel toward the knee. Holding the cuff from sliding, wrap the other endthe over ankle as shown in of the ankle, and step I11 in Figure 20 or 21, again following the contour secure the Velcro fastener. Check to be sure that the corners of the Cuff extending above the upper edge of the cuff are about equal. If one end extends morethan the other, loosen the Velcro and adjust the wrap. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 39 Next, locatethe "over the artery" marker of the cuff, and rotate the so cuff that this line is directly over the posterior tibial artery. The cuff may be. rotated more easily by sliding it toward the malleolus, and after alignment, the cuff can be made snug by pulling it up toward the calf. The cuff should conform closelyto the shapeof the ankle, with the lower edge 1 to 2 112 inches abovethe malleolus. .* The posterior tibial artery is usually palpated as it courses posteriorly to the medial malleolus. Even if the posterior tibial pulse is not palpable, the posterior tibial artery is used as the location for the marker on the line cuff for the "over the artery position". Any kinks in the tubing are removed, and tension on the tubing on the participant's leg is relieved. If needed, masking tapeor hospital clips are applied this at timeto anchor the tubing to the ultrasound table to maintain this position. Explain the blood pressure measurement procedure theascuff is put into place. Be sureto explain that repeated blood pressure measurements will be obtained automatically. Advise the participant that the first inflation is always somewhat uncomfortable due to lack of "individualized" adjustment by the machineto that particular person's blood pressure. Subsequent readings require a lower pressure and will cause less discomfort. If an adequate systolic blood pressure measurement is not obtained the at ankle, verify that the cuff has been wrapped appropriately and has not slipped. If upon inflationthe cuff rolls down toward the foot, the cuff a larger should be reapplied more snugly. If the cuff unwraps upon inflation, cuff may be substituted. If a cuff is rewrapped or changed, an additional manually-triggered BP is taken. Observe the participant for a tendency to "stretch" the calf or wiggle the foot during the blood pressure reading. If it occurs, discuss the effect of this action with the participant before the ultrasound scan is started, stressing the need for the leg and arm to be kept still the blood during pressure readings. Discomfort during the blood pressure measurement may indicate thatthe ankle cuff has been applied too tight,not applied smoothly, or that it is too narrow. Once the ankle blood pressure is completed the cuff is removed the ankle. from The participant's sock and/or blanket is replaced to make the participant comfortable asthe blood pressure procedures move to the arm. 7.5.2 Applying the Blood Pressure Cuff to the Arm Proper size of the cuff is essential for accurate blood pressure measurementsmall adult, adult, Field Centers have four standardized cuffs available large adult, and thigh cuff. The same standardized cuff Sizes are used for sitting blood pressure and for the measurement of postural changes in Ultrasound blood pressure. - Use the cuff size used the for sitting blood pressure measurements, (recorded on the Itinerary Form) for selecting the .of size the Dinamap cuff for the upper extremity. The standard cuffs provided are by the Baum Company for the sitting blood pressure, and by Dinamap for the blood pressure measurements the Ultrasound work station. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 at 40 Once t h e p a r t i c i p a n t i s g i v e n i n s t r u c t i o n s a n d e x p l a n a t i o n s , a n d t h e e q u i p m e n t h a sb e e nc h e c k e d ,b l o o dp r e s s u r em e a s u r e m e n tb e g i n s . The f o l l o w i n g steps must be f o l l o w e d p r e c i s e l y . 1. I f t h e p a r t i c i p a n ti n d i c a t e s t h a t there is a m e d i c a l or p o s t - s u r g i c a l arm, o r reasonfornothavingthebloodpressuremeasuredontheright iftheright arm i s m i s s i n g , p r o c e e d w i t h t h e l e f t arm. I n d i c a t e on t h e I t i n e r a r y Form and on a Note Log t h a t t h e l e f t arm is u s e d . If i n t o h a v e a blood p r e s s u r e t a k e n doubt, or i f t h e p a r t i c i p a n t p r e f e r s n o t on e i t h e r arm, t h e s o n o g r a p h e r s h o u l d c o n s u l t w i t h t h e i r i m m e d i a t e supervisor. 2. I ft h e arm c i r c u m f e r e n c eh a sn o t been measured .at t h eS i t t i n g Blood Pressurestation,havetheparticipantstandfacing awayfrom t h e arm b e n t 90 d e g r e e s ' a t t h e elbow, handon observer with the right ( a t t h e t o p o u t e re d g eo f m i d s e c t i o n . Locate t h e t i p o ft h ea c r o m i o n , t h e s h o u l d e r b l a d e ) andmeasure t h e l e n g t h of t h e u p p e r arm from Mark t h e acromion t o t i p o f elbow u s i n g a c e n t i m e t e r t a p e m e a s u r e . arm a n d t h e n h a v e t h e p a r t i c i p a n t r e l a x t h e arm a t midway p o i n t o f t h e t h e side. Wrap t h e t a p e a r o u n d t h e arm o v e r the midpointmark,making is l e v e l .M e a s u r et h e arm c i r c u m f e r e n c e t o t h e surethatthetape record. See Table 1. below: n e a r e s t1 / 2c e n t i m e t e ra n d T h er a n g em a r k i n g so nc o m m e r c i a lc u f f so v e r l a p from s i z e t o s i z e a n d d o n o t AFUC S t u d y arm s i z e i s m e a s u r e d , a n d t h e o f f e r a precise g u i d e l i n e . I n t h e c u f f s i z e i s selected a s follows: ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 41 Table 1. Determination of cuff size based on arm circumference Cuff Size Arm Circumference < 24 cm to 32 cm 3 3 to 4 1 cm Small Adult Adult Large Adult 24 > Thigh The ultrasound of the part exam 41 cm begins. Before activating the next phase of the study, take a minute to instruct the participant on the "noconversation" rule. Also, remind the participant to "hold questions" about exam results until after the last portion the of ultrasound station exam is completed, since it is important that all participants be "treated the same way". 7.5.3 . Blood Pressure Examination Instructions to position the cuff and to take manual ankle pressure will appear on the ultrasound computer monitor. The computer monitors will display the following messages: . 4 8 6 DELL/CSA MANUAL ANKLE Monitor blood . ..: pressure ' IBM Monitor Ready,to take blood . pressure'. . . . Press M on the IBM keyboard. When yellow light stays cuff press Y and ENTER on DELL/CSA keyboard off, . . . . P Press M on the IBM keyboard. If an adequate systolic blood pressure measurement is not obtained the at ankle, the sonographer verifies that the cuff has been wrapped appropriately and has not slipped. If upon inflation the cuff rolls downtoward the foot, the cuff should be reapplied more snugly. If the cuff unwraps upon inflation, a larger cuff may be substituted. If a cuff is rewrapped or changed, an additional manually-triggered BP is taken. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 42 IBM ComputerMonitor 4 8 6 ComputerMonitor Ready t o t a k e b l o o d p r e s s u r e MAMJAL ANKLE b l o o d p r e s s u r e Press M on t h e IBM keyboard. When y e l l o w c u f f l i g h t Received command t o t a k e manualbp T h i s w i l l c a l i b r a t e t h e dinamap stays o f f , p r e s s Y and ENTER on DELL/CSA kevboard A f t e r t h e manual blood pressure . . . . .. . .. .. i s t a k e n t h e s c r e e n s w i l l read: . . IBM CombutetMonitor 486 Computer Monitor Ready t o t a k e b l o o d p r e s s u r e MANUAL ANKLE b l o o d p r e s s u r e Press M on t h e IBM keyboard. When y e l l o w c u f f l i g h t Received command t o t a k e manualbp T h i s w i l l c a l i b r a t e t h e dinamap stays o f f , p r e s s , Y a n d ENTER on DELL/CSA keyboard Ready t o t a k e b l o o d p r e s s u r e Press Y and ENTER on t h e 4 8 6 computerkeyboard. 4 8 6 Computer Monitor COMPUTER ANKLE I IBM Computer Monitor Ready t o t a k e b l o o d p r e s s u r e . P r e s s A on t h e IBM keyboard. When y e l l o w c u f f l i g h t stays off, p r e s s Y and ENTER on DELL/CSA keyboard Received..command t o t a k e manualbp T h i s w i l l c a l i b r a t e t h e dinamap:. I.I . .. .. .. . Readv- to t a k e b l o o d D r e s s u r e ARIC PROTOCOL 6a.UltrasoundScanningProcedures - V i s i t 3 VERSION 3.0 01/95 43 Press A and ENTER on . .. the IBM kevboard. .. . . . Received command to take manualbp This will calibrate the dinamap COMPUTER ANKLE . Computer Monitor IBM 486 ComputerMonitor P r e s s A on t h e IBM keyboard. Ready to take blood pressure When yellow c u f f l i g h t s t a y s o f f , Received command t o t a k e a n k l e b p press',Y and ENTER on DELL/CSA keyboard After the data has been collected, a copy of the data sent to the IBM will be copied onto the IBM monitor. The data displayed will look something like this: IBM 486 ComputerMonitor . . . . . . . Computer Monitor . ' Received command to take manualbp This will calibrate the dinamap COMPUTER ANKLE ; , P r e s s A on t h e IBM keyboard. ... Ready .When . . yellow cuff light stays to take blood pressure off, Received p r e s s .Y and ENTER on DELL/CSA keyboard A 12:33.50 command to take anklebp BBA13053400130533093082132068 After the ankle blood pressure is taken and the cuff is fully deflated, the IBM screen will read: .. 486 Computer Monitor ... '. COMPUTER IBM Computer Monitor ANKLE Received command to take anklebp P r e s s A on t h e IBM keyboard. . . Whim yellow c u f f l i g h t s t a y s off, A 12:33.50 BBA13053400130533093082132068 press Y and ENTER on DELL/CSA keyboard Ready t o t a k e b l o o d p r e s s u r e The cuff is removed fromthe ankle. See Section 7.5.2 for arm cuff application. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 44 Press Y and ENTER o n t h e 486 computerkeyboard. thenread: The computermonitors will IBM . Computer Monitor 4 8 6 ComputerMonitor MANUAL ARM Received command t o t a k e a n k l e b p P r e s s M on t h e IBM keyboard. A 12:33.50~BBA13053400130533093082132068 When y e l l o w c u f f l i g h t s t a y s o f f , Ready t o t a k e b l o o d p r e s s u r e press Y and ENTER on DELL/CSA keyboard Press M on t h e IBM k e y b o a r d .S h o r t l ya f t e r M i s p r e s s e d on t h e IBM keyboard, t h e IBM computer w i l l append t h e f o l l o w i n g messageon t h e s c r e e n : IBM Computer Monitor 4 8 6 Computer Monitor Received command t o t a k e a n k l e bp MANUAL ARM i P r e s s M on t h e IBM keyboard. A 12:33.50 When'yellowcufflightstaysoff, Ready t o t a k e b l o o d p r e s s u r e " p r e s s Y.and ENTER on DELL/CSA keyboard' T h i s w i l l c a l i b r a t e t h e dinamap After the .. /I' ,: , manualbloodpressure 4 8 6 Computer .Monitor MANUAL ARM P r e s s M on t h e IBM keyboard. BBA13053400130533093082132068 Received command t o t a k e manualbp i s t a k e n , t h e IBM s c r e e n w i l l read: I IBM Computer Monitor Ready t o t a k e b l o o d p r e s s u r e Received command t o t a k e manualbp T h i s w i l l c a l i b r a t e t h e dinamap When y e l l o w c u f f l i g h t s t a y s o f f , .. . . ' p r e s s Y and ENTER on DELL/CSA Ready t o t a k e b l o o d pressure keyboard ARIC PROTOCOL 6a.UltrasoundScanningProcedures - Visit 3 VERSION 3.0 01/95 45 Press Y and ENTER 4 8 6 computerkeyboard. IBM Computer Monitor 4 8 6 Computer Monitor Ready t o t a k e blood pressure COMPUTER ARM Press B on t h e IBM keyboard. Received- command t o t a k e manual bp T h i s w i l l c a l i b r a t e t h e dinamap To CONTINUE p r e s s Y and ENTER on DELL/CSA keyboard Ready t o t a k e b l o o d p r e s s u r e Press B and ENTER on t h e IBM keyboard. 4 8 6 Computer Monitor 1' COMPUTER ARM . Press B on t h e IBM keyboard. I IBM Computer Monitor Ready bt p a l ok r te oeosds u r e Received command t o t a k e manual bp T h i s w i l l c a l i b r a t e t h e dinamap To CONTINUE: . Ready t o t a k e blood pressure . p r e s s Y and ENTER on DELL/CSA keyboard Received command t o t a k e arm bp Press Y and ENTER on t h e 4 8 6 computerkeyboard to continue. A f t e r t h e d a t a h a s been c o l l e c t e d , a copy of t h e d a t a s e n t t o t h e IBM w i l l be copiedonto t h e I B M monitor. The datadisplayed w i l l looksomething l i k e this: 4 8 6 Computer Monitor .COMPUTER ARM IBM Computer Monitor Received command t o t a k e manualbp T h i s w i l l c a l i b r a t e t h e dinamap Pres's B on t h e IBM keyboard. Ready t o t a k e blood pressure To CONTINLIE Received command t o t a k e arm bp p r e s s Y and ENTER on DELL/CSA keyboard B 12:33.50 ARIC PROTOCOL 6a.UltrasoundScanningProcedures BBA1305340013053309308~132068 - V i s i t 3 VERSION 3.0 0 1 / 9 5 46 After the arm blood pressure is taken and the cuff is fully deflated, the IBM screen will read: 486 . Computer IBM Computer Monitor This COMPUTER ARM . Press B on the IBM keyboard. . . will calibrate the Ready to takeblood Received commandto take Monitor dinamap pressure . TO.CONTINUE ' p r e s s Y and ENTERon DELL/CSA armbp B 12:33.50 BBA13053400130533093082132068 keyboard Ready to take blood pressure Arm blood pressures will be taken intermittently during ultrasound. The CSA/Dell will prompt the sonographer for BP initiation. At the endof the study, the program is automatically exited. The program creates a file containing the recorded blood pressures, which is placed "studies" directory. The file is named with the participant ID the as file name and bpas its extension, i.e., X******.bp, where X represents the field center code, and the asterisks represent the participant ID number. in At the conclusion of the examination, the sonographer copies the blood pressures files onto a floppy diskette along with the other participant files, and sends the diskette along with the videotape to the Ultrasound Reading Center. 7.6 Preparation for ultrasound Examination The subject is in a supine position with his/her legs resting comfortably on a pillow. The participant's position should allow head rotation to either side. The sonographer is seated at the end of the exam table that is nearer the participant's head. The top of the participant's head is about one to three inches fromthe end of the exam table,so as to afford easy access to the sonographer of the areas of the neck to be scanned. When the 486 computer screen reads: Insert Tape and Diskette and Press ENTER when ready Insert tape and diskette, and press ENTER. 486 The computer screen will read: Press Record Press RECORD on Sonographer Box. The NEC PC-VCR is automatically placed in the RECORD mode by the computer. A red circle on theVCR front panel indicates that this VCR is recording. A study code flow screen will appear on the 486 monitor. The text will be color coded as follows: Yellow highlight indicates that a code is to scanned. be Pink highlight indicates thata code is to be scanned next.. - ARIC PROTOCOL 6a. Ultrasound Scanning ProceduresVisit 3 VERSION 3.0 01/95 the 47 Green h i g h l i g h t i n d i c a t e s t h a t The 486 computerscreen looks l i k e t h i s : a codehas been scanned. PRESS RECORD TO START I1 IBM Computer Monitor 4 8 6 ComputerMonitor *** screen, which w i l l now d i s p l a y t h e f i r s t s c a n n i n g *** 012 Start Code/Calibration 048 R i g h t Common Optimal 080 RightBulbOptimal 112 R i g hItn t e r n a l 084 RightBulbFar 092 R i g h t B u l b Near Ready t o t a k e b l o o d ' p r e s s u r e .. Receivea .command t o t a k e arm bp , .. B 12: 33.50 BBA13053400130533093082132068 Ready t o t a k e b l o o d p r e s s u r e The 486 computer i s now r e a d y f o r t h e s t a n d a r d p r o c e d u r e f o r a B-mode u l t r a s o u n d scan of t h e r i g h t s i d e . I n s t r u c t i o n s f o r s c a n n i n g t h e r i g h t s i d e are d i s c u s s e d i n S e c t i o n 8 . 2 . fter t h e r i a h t s c a n , h e computer monitors which may o r may n o t i n c l u d e w i l l read: 4 8 6 ComputerMonitor .. COMPUTER ARM . . Q C s , hasbeencompleted, IBM Computer Monitor ' Ready t o t a k e " b 1 o o d ; ' p r e s s u r. e. . . . . . . . .. . . . Press B on t h e IBM keyboard. Received. command .to t a k e arm bp To CONTINUE B. 12 :33.50 BBA13053400130533093082132068 p r e s s Y and ENTER on DELL/CSA keyboard Ready t o t a k e b l o o d p r e s s u r e ' . ' :. Press B on t h e I B M kevboard. ARIC PROTOCOL 6a.UltrasoundScanningProcedures - V i s i t 3 VERSION 3.0 01/95 48 486 ComputerMonitor . IBM ComputerMonitor Received command t o t a k e arm bp COMPUTER ARM P r e s s B on t h e IBM keyboard. B 12:33.50 BBA13053400130533093082132068 Ready t o t a k e b l o o d p r e s s u r e To CONTINUE p r e s s Y and ENTER on DELL/CSA keyboard Received command to t a k e arm bp A f t e r t h e d a t a h a s been c o l l e c t e d , a copy of t h e d a t a s e n t t o t h e IBM w i l l b e c o p i e d o n t o t h e IBM monitor. 486 ComputerMonitor B 12:33.50 COMPUTER ARM P r e s s B on t h e IBM keyboard. BBA13053400130533093082132068 Ready t o t a k e b l o o d p r e s s u r e Received command t o t a k e arm bp To CONTINUE p r e s s Y and ENTER keyboard IBM Comnuter Monitor on DELL/CSA A f t e r t h e arm b l o o d p r e s s u r e screen w i l l r e a d : B 12:33.50 BBA13053400130533093082132068 is t a k e n and t h e c u f f i s f u l l y d e f l a t e d , t h e 4 8 6 ComputerMonitor COMPUTER ARM P r e s s B on t h e IBM keyboard. To CONTINUE p r e s s Y and ENTER on DELL/CSA keyboard B 12:33.50 IBM IBM ComputerMonitor BBA13053400130533093082132068 Ready t o t a k e b l o o d p r e s s u r e Received command t o t a k e arm bp B 12:33.50 BBA13053400130533093082132068 Ready t o t a k e b l o o d p r e s s u r e ARIC PROTOCOL 6a. UltrasoundScanningProcedures - V i s i t 3 VERSION 3.0 01/95 49 P r e s s Y and ENTER o nt h e 4 8 6 computerkevboarq. -The l e f t side menu 8creen w i l l a p p e a r on t h e 486 monitorand w i l l look l i k e t h i s : . - IBM Computer Monitor 486 ComputerMonitor 032 L e f t Common Optimal 064 L e f t B u l b Optimal 096 L e fIt n t e r n a l 068 L e f tB u l b Far 076 L e f tB u l b Near B 12:33.50 ' . ' BBA13053400130533093082132068 After t h e s c a n of t h e l e f t s i d e h a s b e e n c o m p l e t e d . T h e m e s s a g e s o n t h e c o m p u t e rs c r e e n s w i l l read as f o l l o w s : 486 ComputerMonitor SITTING p r e s s u r e Press S on t h e IBM keyboard. When y e l l o w c u f f l i g h t s t a y s off, press Y a n d ENTER on D e l l / C S A keyboard .F B 12 :33'.50 BBA13053400130533093082132068~ - The s o n o g r a p h e r e x p l a i n s t o t h e p a r t i c i p a n t t h a t s i t t i n g a n d s t a n d i n g b l o o d p r e s s u r e s w i l l now b et a k e n . The s o n o g r a p h e r s h o u l d i n s t r u c t t h e participant to rest q u i e t l y d u r i n g t h e s e b l o o d pressures and assist t h e p a r t i c i p a n t t o t h e s ep o s i t i o n sw i t h as little movement a s possible. F o l l o w i n gt h e s e guidelines,thesonographerthenaskstheparticipant t o sit. ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - Visit 3 VERSION 3.0 0 1 / 9 5 50 Press S on t h e IBM keyboard. 486 Computer Monitor The IBM screen w i l l read: I IBM Computer Monitor Ready t o t a k e blood p r e s s u r e Received command t o t a k e arm bp B 12:33.50 BBA13053400130533093082132068 Ready t o t a k e blood p r e s s u r e Received command t o take s i t t i n g bp a f t e r 30 sec. The IBM computer w i l l automatically wait t h e 30 seconds required before taking seated i n t h e protocol.After t h e d a t a h a s been c o l l e c t e d , a copy bloodpressure,asrequired of t h e d a t a s e n t t o t h e IBM w i l l becopiedonto t h e IBM monitor. T h e data displayed w i l l looksomething l i k e t h i s : A f t e r t h e seated blood pressure w i l l read: .. . ... .. . .. .... .... .......... .: . .. . . .. ................. '.'.::,'":'488~''6~ iter udnitor .. . . ...... ..... . .. .. .... . ...... . . . . . . . . . . ... . . .. . . . SITTING p r e s s u r e ..... .. ........ .... .... . :,.:.. ... .... .. . .. . .. ... ... .. . . ... ... . .. .. .. . . . . . . .: is taken and t h e cuff i s f u l l y d e f l a t e d , t h e IBM screen IBM Computer Monitor Ready t o t a k e blood p r e s s u r e . . . ... .. .. . Pres;k the .. ..S ..on.' ..... ..... .... ... . . .. . . . . . . . . . . ... ... . . . ... . . . . . ... .. .... . .. :. . ,. .: , . ...... When..yellow'. .. .. ; ;.. ' . . . . . #,.,:, . . . . . .' ;ore-". c 11 p r e s s ' Y 'and . keyboard. ... . u f ' IBM keyboard. Received command t o t a k e s i t t i n g bp a f t e r 30 sec. . S 12:33.50 BBA13053400130533093082132068 f ' f i g h t sst taayyss ENTER on Dell/CSA Ready t o t a k e blood p r e s s u r e .. ... ... .. .. .. .. . . . .. , ARIC PROTOCOL 6a.UltrasoundScanningProcedures - V i s i t 3 VERSION 3.0 01/95 51 Press Y and ENTER on the 486 c o m w t e r keyboard. IBM .Computer 486 Computer Monitor First STANDING The 486 screen will now read: Ready t o take blood Monitor pressure pressure Received command.to Press T on the IBM keyboard. take.sitting bp after 30 sec. . . S 12:33.50~BBA13053400130533093082132068 When yellow cuff light stays off, press Y and ENTER on Dell/CSA keyboard ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 52 The the ha8 IBM IBM computer will automatically wait the 30 seconds required before taking first standing blood pressure,a s required in the protocol. After the data been collected,a copy of the data sent to the IBM will be copied onto the monitor. The data displayed will look something like this: After the first standing pressure is taken and the cuff is fully deflated, the IBM screen willread: - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 53 Press Y and ENTER on 486 Computer the 486 compul m. The 486 screen will now read: IBM Computer Monitor Monitor . . A SECOND will be STANDING pressure taken after 20 seconds v. When yellow cufflight stays off, press Y and ENTER on Dell/CSA keyboard Ready t o take .blood pressure ... . Received command to after 30 sec. . . takefirst standing b p . . ' .. T : 12 :33.50 BBA13053400130533093082132068 A second.standing bp will taken in.twenty The second standing blood dictated by the protocol. . .. . ... .. ...... ... ....... ..... ... .. ................ ...... ............. ............... .. . ....... ... .. ... . . . . "f486'Computer . .. ...... ......... .... ..... .. ... .. ... . . ,.' .. ..;.,..:.: ..;:..... .. . .. .. .'::... STANDING . . A,' . , .. .. ,. ............... ........ wili be taken sicom pressure will be taken The IBM will read: IBM Computer Monitor pre.ssure after 20 seconds automatically at the Received command to after 30 sec. timeinterval Monitor takefirst standing bp T 12:33.50 BBA13053400130533093082132068 A second standing bp will taken in twenty seconds Ready to take blood pressure Received command t o take After the data has been collected, a copy of the data - sent second to standingbp the IBM will be copied ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 54 Left Leg Fabric Velcro "Ears" about equal Medial malleous Figure 20. Blood Pressure Cuff Placement - Left Ankle - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 55 Right Leg Fabr on "Ears" about equal Medial malleous Figure 21 Blood Pressure Cuff Placement - Right Ankle ARIC PROTOCOL 6a.UltrasoundScanningProcedures - V i s i t 3 VERSION 3 . 0 01/95 56 CAROTID 8. SCANS Orientation of theparticipant's head as follows. The participant is asked t o look straight up at the ceiling. A triangular shaped, firm foam rubber wedge shaped in a 45-45-90 degree form is used position to the head in a standard way. The wedge is placed on the examination table, with largest surface of the wedge facing down. It is placed on the examination table next to the side of the neck to be evaluated in a such way that the 90Y angle is furthest from the midline of theface. This positions the45# angle closest t o midline. The wedge is then gently pushed toward the midline of the head until the 45# angle edge touches thescalp. The participant i s then asked t o rotate his head toward the foam rubber wedge until the side of the head just above the ear rests againstit. The chin may be raised slightly and the shoulder adjusted slightly for bettervisualization. The ultrasound equipment is positioned so that the sonographer has access to the participant's neck, all instrument controls and foot pedals. 8.1 Calibration A calibration is done before each scan. followed in ordert o standardize the The following settings must be calibration procedure. The Phase 2 settings should beas follows: the gain is set at 5 0 % , the TGC is in a stair step alignment the focus is in the mid focus setting (2cm) The transducer motor is and on there should not be any gel on the transducer. The monitor displays will read follows: as 486 *** Computer Monitor PRESS RECORD TO START . . . ... .. *** Ready to . . .. . IBM. Computer . . .. .. . Monitor :' ' .. take.blood pressure 012 Start Code/Calibration Received command to 048 Right Common Optimal 080 Right Bulb Optimal 112 Right Internal takearm bp-, B 12 :3 3 . 5 0 BBA13053400130533093082132068 .. . . Ready to take blood pressure . 084 Right Bulb Far 092 Right Bulb Near .. . . . . . . I Verify that 012 Start Code/Calibration is highlighted in yellow. TO mark this and each following site, choose SELECT by using the SELECT footswitch. The SELECT messagewill. appear on the flow screen for approximately 10 seconds. After pressing SELECTfootswitch, wait for 7 seconds, then press NEXT SITE footswitch t o move to thenext site to bescanned. The yellow highlight moves to the next code, and the previous codeis highlighted in green. "Do Preliminary Scan Now Press N e x t Site Footswitchwhen finished" appears on screen of the CSA/Dell. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures- Visit 3 VERSION 3.0 0 1 / 9 5 1 57 8.2 RigC h ta r o t S i dc a n neck a r e p o s i t i o n e d f o r t h e exam o f t h e r i g h t c a r o t i d . T h e foam Theheadand is r o t a t e d r u b b e r wedge i s p l a c e d o n p a r t i c i p a n t ' s l e f t s i d e , a n d t h e h e a d t o w a r d t h e foamrubber a s o u t l i n e d i n t h e i n t r o d u c t i o n to this section. 8.2.1 Preliminary t h e common c a r o t i d a r t e r y i s p e r f o r m e d w i t h t h e p a t i e n t as shown i n F i g u r e 26.The h e a dp o s i t i o na n dt r a n s d u c e ri n t e r r o g a t i o na n g l e scan i s t o l e a r n t h e a r t e r i a l geometryand p u r p o s e of t h i s p o r t i o n o f t h e orientationoftheparticipant.Usingfinetransducerangulationstoclearly displaytheblood-intimaboundarieswithin the vessel,thetransducer is s l o w l y moved t o w a r d t h e m a n d i b l e u n t i l t h e w i d e n i n g o f t h e c a r o t i d b u l b , a n d f i n a l l y t h e i n t e r n a l a n de x t e r n a lc a r o t i d arteries, are v i s u a l i z e d . U s i n g t h e knowledgeoftherelativeorientationoftheinternalandexternalcarotids from t h i s s c a n , t h e o p t i m a l a n g l e w h i c h s h o u l d b e s t d i s p l a y t h e t i p of t h e i n F i g u r e s 22-25.The f l o w d i v i d e r may b ed e t e r m i n e du s i n gt h ed i a g r a m s i s now s c a n n e d l o n g i t u d i n a l l y a t t h i s entirelengthofeachcarotidsystem oDtimal i n t e r r o u a t i o n a n u l e t o p r o v i d e a n o v e r a l l q u a l i t a t i v e i m p r e s s i o n of theextentandseverityofdiseaseandthequalityoftheimage at this or p o s s i b l el e s i o n s a r e i n t e r r o g a t i o na n g l e .U n u s u a la n a t o m i cf e a t u r e s o b s e r v e d . O r a l comments are r e c o r d e dd u r i n gt h ee x p l o r a t o r ys c a n t o assist the reader during the reading process. A transverse scan of 8.2.4Thecursor i s p l a c e di nt h e" D o p p l e r " mode o nt h eB i o s o u n di n s t r u m e n t p a n e l . The s o n o g r a p h e rd e t e r m i n e sw h i c ha r t e r y is t h ei n t e r n a lc a r o t i d a r t e r y . The c u r s o r i s f i r s t moved i n t o o n e b r a n c h a n d t h e n t h e o t h e r . Doppler s p e c t r a o n The Doppler key i s d e p r e s s e d i n o r d e r t o v i e w t h e i s p r e s s e da g a i n t o s t o p t h e theBiosoundscreen.TheDopplerkey d o p p l e r mode u n t i l t h e s o n o g r a p h e r i s r e a d y t o v i e w t h e D o p p l e r spectra a g a i n .T h i s is r e p e a t e di ne a c hb r a n c h .T h ei n t e r n a lc a r o t i da r t e r y is i d e n t i f i e d , b a s e d o n t h e c r i t e r i a o u t l i n e di nS e c t i o n6 . 2 . 5 .P r e s s t h e DOP CUR key t o remove t h eD o p p l e rc u r s o rf r o ms c r e e n .T h e p r e l i m i n a r y s c a n i s complete. 8.2.5 T o p u tt h ec r o s s h a i rc u r s o r on t h e t a p e f o r l a n d m a r k i d e n t i f i c a t i o n , d o t h ef o l l o w i n g : a. b. Press t h e t h i r d menu key t o d i s p l a y t h e C a l c u l a t e menu. P r e s st h ef i r s t menu key t od i s p l a yD i s t a n c e menu. C. P r e s st h ef i r s t menu k e ya g a i nf o r" D i s t a n c e plus". The c u r s o r w i l l appear i nt h eu p p e rp o r t i o no f t h e screen. Place c r o s s - h a i r in posit ion. t o u s u a lr a n g e( 3 0 - 5 0 % ) ,a n da d j u s t TGC s e t t i n g s d .A d j u s tv i d e og a i n TGC minimum o n r i g h t ( t o p ) , maximum on f o ro p t i m a li m a g i n g . l e f t( b o t t o m )( s t a i r s t e pc o n f i g u r a t i o n ) . - 8 . 2 . 6T h es o n o g r a p h e rv e r i f i e st h a tt h ec o m p u t e rm o n i t o ri n d i c a t e st h e COMMON OPTIMAL i s t o b e s c a n n e d . RIGHT - i s moved p r o x i m a l l y ( t o w a r d o r i g i n heart) 8 . 2 . 7T h eu l t r a s o u n dt r a n s d u c e r to view the distal centimeter of the right common c a r o t i d a r t e r y . ARIC PROTOCOL 6a.UltrasoundScanningProcedures - Visit 3 VERSION 3.0 01/95 58 The cursor is placed in the lumen as described in Section 6.3.2. The best possible image of the right common carotid artery the in optimal angle is obtained as outlined in Section6.1 and 6.2.3. 8.2.8 The sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles, marking the onsite video tape. 8.2.9 When the sonographer is ready to image the next site he/she presses the NEXT SITE footswitch or presses the NEXT SITE switch on the sonographer box to advance the program to the next site. Confirm advancement of the program by verifyuing that the next site to be scanned in highlighted inyellow. 8.2.10 ' The transducer is moved distally to the bifurcation area. The cursor Ps placed at the tipof the flow divider (Section 6.3.3). The arterial interfaces are optimized at this site and angle. 8.2.11 The computer monitor indicates RIGHT BIFURCATION. The sonographer optimizes the arterial interfaces at this site, andthewhen best possible image is obtained as outlined in Sections 6.1 and 6.2.4, presses the SELECT footswitch and holds the image for at least five cardiac cycles, marking the site on videotape. 8.2.12 When the sonographer is ready to image the RIGHT INTERNAL CAROTID, he/she presses the NEXT SITE footswitch or presses the NEXT SITE switch on the sonographer box to advance the programto the next site. 8.2.13 The transducer is moved distally to the proximal centimeter of the internal carotid artery. 8.2.14 The computer monitor indicates RIGHT INTERNAL CAROTID. The cursor is placed into the correct position at the tip ofthe flow divider as discussed in Section 6.3.4. The sonographer optimizesthe far wall arterial interfaces. When the best possible image,as outlined in Sections 6.2.2 and 6.2.5, are obtained,the sonographer presses the SELECT footswitch and holds the image at least five cardiac cycles, marking the onsite video tape. 8.2.15 8.2.16 When the sonographer is ready to image the RIGHT BIFURCATION FAR WALL, he/she presses the NEXT SITE footswitch or presses the NEXT SITE switchon the sonographer box to advance the program to the next site. The computer monitor indicates RIGHT BIFURCATION FAR WALL, OPTIMAL The transduceris moved backto the bifurcation areato obtain an image of the bifurcation at the optimal angle. The cursor is placed at the tip of the flow divider 6.3.3). (Section The transducer is slowly tilted along the arterial so axis that the far. wall of the bifurcation becomes vertical the in centerof the display screen. The sonographer optimizes the intima-media interfaces on the far wall. During this maneuver,the near wall echoes willdeteriorate. When the far wall interface echoes at0 optimized, as outlined in Section 6.2.6.1, the sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles, marking the site on video tape. ANGLE. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 for 59 8.2.17 When t h e s o n o g r a p h e r i s ready t o image t h e R I G H T BIFURCATION NEAR h e / s h e p r e s s e s t h e NEXT SITE f o o t s w i t c h or p r e s s e s t h e NEXT SITE switchonthesonographer box t o a d v a n c e t h e p r o g r a m t o t h e next site. 8.2.ia Thecomputermonitorshouldindicatethe R I G H T BIFURCATION NEAR WALL, OPTIMAL ANGLE. The t r a n s d u c e r i s s l o w l y t i l t e d a l o n g t h e arterial axisbacktowardstheoptimalangleandthenbeyond so t h a t t h e n e a r w a l l of t h e b i f u r c a t i o n becomes v e r t i c a l i n t h e center o f t h e d i s p l a y screen. The c u r s o r is p l a c e d a t t h e t i p of 6.3.3). The s o n o g r a p h e ro p t i m i z e st h e t h ef l o wd i v i d e r( S e c t i o n wall. D u r i n gt h i sm a n e u v e r , m e d i a - i n t i m ai n t e r f a c e so nt h en e a r t h e f a r w a l l e c h o e s w i l l d e t e r i o r a t e . When t h e n e a r wall i n t e r f a c e e c h o e s a r e o p t i m i z e d , a s o u t l i n e d i n S e c t i o n 6.2.6.2, thesonographerpresses t h e SELECT f o o t s w i t c h a n d h o l d s t h e i m a g e f o r a t l e a s t f i v e cardiac c y c l e s , m a r k i n g t h e s i t e on v i d e o t a p e . Thesonographerremovesthetransducerfromtheneckandpressee t h e NEXT S I T E f o o t s w i t c h . 8.2.19 Thesonographerlooks a t t h e computer monitor t o see i f a s i t e w i l l be r e p e a t e d o n t h e r i g h t s i d e f o r q u a l i t y a s s u r a n c e p u r p o s e s (QC s i t e ) . I f no QC s i t e s c a n i s r e q u i r e d o n t h e r i g h t s i d e , t h e s o n o g r a p h e r p r e s s e s t h e NEXT S I T E f o o t s w i t c h a g a i n . u, If a QC s i t e s c a n i s required, t h em o n i t o d r i s p l a y si, n red, t h e and t h e f l o ws c r e e nh i g h l i g h t s t h e code. T h e sonographer QC s i t e andangle; moves t h e cursor t o t h e o b t a i n s a n imageofthe 8.2.20 QC s i t e a p p r o p r i a t el a n d m a r ka n do p t i m i z e st h e arterial interfaces. When t h e best p o s s i b l e image h a s b e e n o b t a i n e d , h e / s h e p r e s s e s t h e SELECT f o o t s w i t c h a n d h o l d s t h e image f o r a t l e a s t f i v e cardiac cycles,markingthe s i t e on v i d e o t a p e . 8.2.21 T h seo n o g r a p h epr r e s s e s NEXT S I T E s w i t c h e o s nt h se o n o g r a p h e r o r on t h e NEXT SITE f o o t s w i t c h . 8.2.22 The g e l i s wiped from t h ep a r t i c i p a n t ' sn e c k a, n dt h eh e a da n d n e c k are r e p o s i t i o n e d f o r t h e l e f t s i d e scan. 8.2.23 The arm b l o opdr e s s u rsec r e e n follow directions on the screen measurement. w i l l a p p e a r . The s o n o g r a p h esrh o u l d . t o completebloodpressure 486 ComputerMonitor COMPUTER ARM IBM.Computer Monitor B 12:33.50~~BBA13053400130533093082132068 .. Press B on t h e B IM keyboard. Ready t o t a k e b l o o d p r e s s u r e To Received command t o ' t a k e arm b p CONTINUE Press Y and ENTER on DELL/CSA box ' B 12:33.50 BBA13053400130533093082132068 computer. Ready to t a k e blood p r e s s u r e ARIC PROTOCOL 6a. UltrasoundScanningProcedures - V i s i t 3 VERSION 3.0 01/95 60 lress B on the IBM computer k e v b o a r L 486 Computer . screens will now read: IBM Computer Monitor Monitor . . . . . . . ...... .. .. ... . . .. .. .. . . . . Ready to COMPUTER ARM . . . take blood pressure . Pre'ss B.'on the .. .. ... .. .... .. . . ....... .. .. . .. . .. . . . .. . &(.;:i: The ~ Received command to IBM keyboard. takearm bp B 12:33.50 BBA13053400130533093082132068 CONTINUE . . . . . . . ..... . .. ......... ....:: ......... ....... .. .. .:... .. .... ... . ..: . ..........:.:.. .:..> ......... . . 'Y'Iand..ENTER on DELC/CSA. .,'Press ..' c.omput,er .: . . . .... . . . . . . ... .. . . .'. Ready t o take blood pressure .... . . . . . . . ..... .. ... ..... .... ... . ... .... ... .. .. . . . . . ' Received command to takearm bD copy of the data sentt o t h eIBX will a displayed will look something like IBM Received Comnuter command to be Monitor takearm bp B 12:33.50 BBA13053400130533093082132068 Ready to take blood Received command to B 12:33.50 After the arm.blood screen will read: pressure is pressure take arm bp BBA13053400130533093082132068 taken and the cuff is fully deflated, theIBM . . .......... ... ... .... ...... .. . .. . .. . ..:. . . .. .. .... . .. . . . . ................. .:... . .:.::.': . . . ..... . .:/.' . .............. . . : . 486'Computer wonitor. ..... ..... .. .................. .. . .. . . . . . . ... ... .... ...... .. .... .. . . . :.. ..:::?;. : :.:: COMPUTER . . . .. .. .. . . . .. .. . . . ... . .. . . . .. . . .. . . ....... ......... ........ ..... ..... .... .. ... .. . . . ..... :. . P .r.e s s :B : ,on the. IBM .keyboard.. .... .. .. ... .... ..... . .. . . .. . . . . "To.:.. . . . CONTINUE . . .. .. .. . . .. . . . . . . ... .. . . . .. . . . . . . . . . . . . . . . . . .. . ..'. ; IBM Computer ... B 12:33.50 Ready to Monitor BBA13053400130533093082132068 take blood Received command to pressure take arm bp . Press:Y.' and,ENTER on DELL/CSA computet: . . . . ... . .. . . .. . .. .... .. .... .. ........ .. ..... . . .. .. ... ... . ... .. .. .. . . . . . . : . : ......... . .. . B 12:33.50 Ready to BBA13053400130533093082132068 take - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures ..... blood pressure Visit 3 VERSION 3.0 01/95 61 P r e s s Y and ENTER on t h e 486 computerkevboard.The IBM Computer Monitor.. 4 8 6 ComputerMonitor *M) PRELIMINARY SCAN NOW 486 s c r e e n w i l l now r e a d : * B 12 :33.50: BBAl3053400130533093082132068 .. .';,Readyt o t a k eb l o o dp r e s s u r e . PRESS NEXT SITE WHEN DONE . . . .. . .. . ' ..' . . . . . arm. bp, . .Received 'coruiand'to take . .. . . . . . .. . .. B.'12 :.33; 5 0. .~.~ A 1 3 0 S 3 4 0 0 1 3 0 5 3 3 0 9 3 0 8 2 1 3 2 0 6 8 . . ..: ... 8.2.24 . .. , ., .. . . . . .... ........ ..... ... . . "'t.a.$e .. .. .. . . .. . . pressure . . . . . . . Thesonographer now e n t e r s comments o n l o g s h e e t f o r r e f e r e n c e l a t e r when computer comments w i l l b er e q u i r e d . Please n o t e t h a t t h e VCR w i l l c o n t i n u e i n RECORD mode. 8.3 L e f t Carotid Scan 8.3.1 Theheadandneck are p o s i t i o n e d f o r t h e exam o f t h e l e f t c a r o t i d . foam r u b b e r wedge is p l a c e d o n t h e p a r t i c i p a n t ' s r i g h t s i d e a n d t h e head i s r o t a t e d t o w a r d t h e foam r u b b e r p i l l o w as o u t l i n e d i n t h e i n t r o d u c t i o n of t h i s s e c t i o n . 8.3.2 "DO P r e l i m i n a r y S c a n monitor. 8.3.3 A transversescanofthe 8.3.4 . now, p r e s s n e x t The s i t e when done" message appears on common c a r o t i d a r t e r y i s f i r s t p e r f o r m e d w i t h the patient head'position andtransducerinterrogationangle as shown i n F i g u r e s 26-29. U s i n gf i n et r a n s d u c e ra n g u l a t i o n s t o c l e a r l yd i s p l a y is s l o w l y the blood-intima boundaries within the vessel, the transducer moved t o w a r d t h e m a n d i b l e u n t i l t h e w i d e n i n g o f t h e carotid bulb, and f i n a l l y t h e i n t e r n a l and e x t e r n a l c a r o t i d a r t e r i e s , are v i s u a l i z e d . U s i n g t h e knowledgeof t h e r e l a t i v e o r i e n t a t i o n o f t h e i n t e r n a l a n d which s h o u l d b e s t e x t e r n a l c a r o t i d s from t h i s s c a n , t h e o p t i m a l a n g l e d i s p l a y t h e t i p of t h e f l o w d i v i d e r m a y . b e d e t e r m i n e d u s i n g t h e is d i a g r a m s i n F i g u r e s 26-29. The e n t i r e l e n g t h of e a c h c a r o t i d s y s t e m now s c a n n e d l o n g i t u d i n a l l y a t t h i s o p t i m a l i n t e r r o a a t i o n a n s l e to p r o v i d e an o v e r a l l q u a l i t a t i v e i m p r e s s i o n o f t h e e x t e n t and s e v e r i t y of disease and t h e q u a l i t y of t h e image a t t h i s i n t e r r o g a t i o n a n g l e . U n u s u a la n a t o m i cf e a t u r e so rp o s s i b l el e s i o n s a r e o b s e r v e d . Oral comments are r e c o r d e d d u r i n g t h e e x p l o r a t o r y s c a n t o assist t h e r e a d e r during the reading process. The c u r s o r i s p l a c e d i n t h e "Doppler" mode o n t h e B i o s o u n d i n s t r u m e n t The s o n o g r a p h e rd e t e r m i n e sw h i c ha r t e r y is t h e i n t e r n a l c a r o t i d a r t e r y .T h e . c u r s o r is f i r s t moved i n t o o n e b r a n c h a n d t h e n t h e o t h e r . spectra on The Doppler'key i s d e p r e s s e d i n o r d e r t o v i e w t h e D o p p l e r i s d e p r e s s e da g a i n t o s t o p t h eD o p p l e r . t h eB i o s o u n ds c r e e n . Thekey T h i s i s r e p e a t e di ne a c hb r a n c h . The i n t e r n a l c a r o t i d a r t e r y is i d e n t i f i e d , based on t h e c r i t e r i a o u t l i n e d i n S e c t i o n 6.2.5. panel. ARIC PROTOCOL 6a.UltrasoundScanningProcedures - Visit 3 VERSION 3.0 01/95 62 8.3.5 Thesonographerverifies that thecomputermonitorindicatesthe COMMON OPTIMAL i s t o be s c a n n e d . 8.3.6 Theultrasoundtransducer is moved p r o x i m a l l y t o v i e w t h e d i s t a l c e n t i m e t e r o f t h e common c a r o t i d a r t e r y . T h e c u r s o r i s placed i n t h e common lumen ( S e c t i o n 6 . 3 . 2 ) .T h eb e s tp o s s i b l ei m a g eo ft h el e f t carotid a r t e r y i n t h e o p t i m a l a n g l e is obtained, as o u t l i n e d i n S e c t i o n s6 . 1a n d6 . 2 . 3a n d shown i n F i g u r e 1 9 . 8.3.7 T h es o n o g r a p h e r presses t h e SELECT f o o t s w i t c h a n d h o l d s t h e i m a g e a t l e a s t f i v e cardiac c y c l e s , m a r k i n g t h e s i t e o n v i d e o tape. 8.3.8 When t h e s o n o g r a p h e r i s r e a d y t o image t h e LEFTBIFURCATION, he/she presses NEXT S I T Ef o o t s w i t c h , o r , NEXT SITE on t h e s o n o g r a p h e r b o x to advancetheprogram t o t h e n e x t site. 8.3.9 T h et r a n s d u c e r i s moved d i s t a l l y t o t h e b i f u r c a t i o n area. T h ec u r s o r i s placed a t t h e t i p of t h e f l o w d i v i d e r( S e c t i o n6 . 3 . 3 ) .T h e s o n o g r a p h e ro p t i m i z e st h e a r t e r i a l i n t e r f a c e s a t t h i s s i t e a n da n g l e . LEFT for 8.3.10 T hceo m p u t emr o n i t oi nr d i c a t e s LEFT BIFURCATION. T hs eo n o g r a p h e r o p t i m i z e s t h e a r t e r i a l i n t e r f a c e s a t t h i s s i t e , a n d when t h e best possible image i s o b t a i n e d , a s o u t l i n e d i n S e c t i o n s6 . 1a n d6 . 2 . 4 , presses t h e SELECT f o o t s w i t c h a n d h o l d s t h e i m a g e f o r a t least five cardiaccycles,markingthe s i t e o n v i d e o tape. 8.3.11 When t h e s o n o g r a p h e r i s r e a d y t o image t h e LEFT INTERNAL CAROTID, h e / s h e presses NEXT S I T E footswitch, o r , NEXT S I T E o n t h e s o n o g r a p h e rb o x t o a d v a n c e t h e p r o g r a m t o t h e n e x t s i t e . 8.3.12 T h es o n o g r a p h e r moves t h e t r a n s d u c e r d i s t a l l y centimeter o f t h e i n t e r n a l c a r o t i d a r t e r y . 8.3.13 T h ec o m p u t e rm o n i t o ri n d i c a t e s LEFT INTERNAL CAROTID. T h ec u r s o r i s placed i n t o t h e correct p o s i t i o n t o i n d i c a t e t h e t i p o f t h e flow d i v i d e r a s d i s c u s s e di nS e c t i o n6 . 3 . 4 .T h es o n o g r a p h e r o p t i m i z e s t h e f a r wall a r t e r i a l i n t e r f a c e s , and when t h e best possible image i s o b t a i n e d , a s o u t l i n e d i n S e c t i o n s6 . 2 . 2 and 6.2.5, presses t h e SELECT f o o t s w i t c h a n d h o l d s t h e image f o r a t least f i v e c a r d i a c c y c l e s , m a r k i n g t h e s i t e o n v i d e o tape. 8.3.14 When t h e s o n o g r a p h e r is r e a d y t o image t h e LEFT BIFURCATIONFAR WALL, h e / s h e presses NEXT S I T E f o o t s w i t c h , o r , NEXT S I T E on t h e s o n o g r a p h e rb o x t o a d v a n c e t h e p r o g r a m t o t h e n e x t s i t e . 8.3.15 Thecomputermonitorindicatesthe LEFT BIFURCATION FAR WALL, OPTIMAL ANGLE. T h et r a n s d u c e r i s moved b a c k t o t h e b i f u r c a t i o n area t o o b t a i n a n i m a g e o f t h e b i f u r c a t i o n a t theoptimalangle. T h e c u r s o r i s placed a t t h e t i p of t h e f l o w d i v i d e r ( S e c t i o n 6 . 3 . 3 ) . .T h et r a n s d u c e r i s s l o w l yt i l t e da l o n gt h e arterial axis so t h a t t h e f a r w a l l o f t h e b i f u r c a t i o n b e c o m e s v e r t i c a l i n t h e c e n t e r o ft h ed i s p l a ys c r e e n . T h es o n o g r a p h e ro p t i m i z e st h e i n t i m a - m e d i ai n t e r f a c e so nt h ef a rw a l l .D u r i n gt h i sm a n e u v e r , t h e n e a r wall e c h o e s w i l l d e t e r i o r a t e . When t h e f a r w a l l i n t e r f a c e e c h o e s are o p t i m i z e d ,a so u t l i n e di nS e c t i o n6 . 2 . 6 . 1 , ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - t o theproximal V i s i t 3 VERSION 3.0 0 1 / 9 5 63 thesonographerpressesthe SELECT f o o t s w i t c h a n d h o l d s t h e s i t e o nv i d e o f o r a t least f i v e c a r d i a c c y c l e s , m a r k i n g t h e image tape. When t h e s o n o g r a p h e r i s r e a d y t o image t h e LEFT BIFURCATION, NEAR WALL, h e / s h e presses NEXT S I T E f o o t s w i t c h , or, NEXT S I T E on t h e s o n o g r a p h e r box t o advance the program t o t h e n e x t s i t e . 8.3.16 - Thecomputermonitorindicatesthe LEFT BIFURCATION NEAR WALL. OPTIMAL ANGLE. The t r a n s d u c e r i s s l o w l y t i l t e d a l o n g t h e arterial axisbacktowardtheoptimalangleandthenbeyond, so t h a t t h e n e a r wall of t h e b i f u r c a t i o n becomes v e r t i c a l i n t h e c e n t e r of t h e d i s p l a y screen. The c u r s o r is p l a c e d a t t h e t i p o f t h e f l o w The s o n o g r a p h e ro p t i m i z e st h em e d i a d i v i d e r( S e c t i o n 6.3.3). wall a s o u t l i n e d i n S e c t i o n 6.2.6.2. intima interfaces on the near D u r i n g t h i s maneuver, t h e f a r wall e c h o e s w i l l d e t e r i o r a t e . When t h e near wall i n t e r f a c e e c h o e s are o p t i m i z e d , t h e SELECT f o o t s w i t c h is p r e s s e d and t h e image is h e l d i n v i e w f o r a t least fiveconsecutivecardiaccycles,markingthe s i t e on v i d e o t a p e . T h es o n o g r a p h e rr e m o v e st h et r a n s d u c e rf r o mt h en e c k . 8.3.18 a t t h e PC t o see i f a s i t e w i l l be r e p e a t e d o nt h el e f ts i d ef o rq u a l i t ya s s u r a n c ep u r p o s e s (QC s i t e ) . I f no QC s i t e s c a n i s r e q u i r e d o n t h e l e f t side, t h e s o n o g r a p h e r presses t h e NEXT S I T E f o o t s w i t c h . 8.3.19 If a QC s i t e s c a n i s r e w i r e d t, h em o n i t o rd i s p l a y s , i n red, t h e QC s i t e a n dt h ef l o ws c r e e nh i g h l i g h t st h ec o d e . The sonographer o b t a i n s a n image of t h e QC s i t e and angle; moves t h e c u r s o r t o t h e The sonographerlooks appropriate landmarkandoptimizesthe a r t e r i a l i n t e r f a c e s . When t h e b e s t p o s s i b l e image h a s b e e n o b t a i n e d , h e / s h e p r e s s e s t h e SELECT f o o t s w i t c h a n dh o l d st h ei m a g ef o r a t l e a s t f i v e cardiac cycles,markingthe s i t e o nv i d e ot a p e . The NEXT S I T E f o o t s w i t c h i s p r e s s e d twice t o a d v a n c et h ep r o g r a m t o the optionscreenfordistensibility, which w i l l a p p e a r a s follows: 8.3.20 . 486 Computer Monitor ., .. . . . . ... ' .. ', ..: IBM -Computer.Monitor .. B 12: 33.50- BBAl30S3400130533093082132068 DISTENSIBILITY TRACKING Ready t o . t a k e b l o o d . p ' r e s s u r e TRACK LEFT SIDE EXIT OR SKIP DISTENSIBILITY Received.command'to take arm bp ' B 12: 33.50, BBA13053400130533093082132068 Ready t o t a k e b l o o d p r e s s u r e U s e t h e arrow key t o h i g h l i g h t EXIT OR SKIP i n y e l l o w , a n d p r e s s . ENTER t o advancetheprogramandwipegelfromtheparticipant'sneck. Themessagesonthecomputer screen w i l l prompt t h e s o n o g r a p h e r t o executesittingandstandingbloodpressures, as d e s c r i b e d i n S e c t i o n 1.5. ARIC PROTOCOL 6a.UltrasoundScanningProcedures - Visit 3 VERSION 3.0 01/95 64 8.3.21 Once the automatic blood pressure is finished, the participant is thanked for their cooperation and escorted from theroom. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 65 8.3.22 The sonographer presses Y and ENTER on t h e 4 8 6 keyboard. The s c r e e n w i l l now read: 486 ComputerMonitor . . IBM ComputerMonitor seconds When you see t h e C:\ Ready t o t a k e . b l o o d p r e s s u r e . I Received command t o t a k e second . s t a n d i n g . b p .. Press Y and ENTER on t h e D E u / C S A .. ' w i l l t a k e n i n twenty A secondstandingbp Press E t o E x i t on IBM on t h e IBM 486 .. . . . . .... .. . . . . . . . . .. . . .. " .. .. .. .. .. . . .. . . 'R' 12.33: 50 BBAi3053400130533093082132068 " Press 'E' t o . e x i t . t h e . b pprogr&n!:.'. . .' Press E on t h e IBM keyboard. The IBM bloodpressureprogram is . a u t o m a t i c a l l ye x i t e d . The program c r e a t e s a f i l ec o n t a i n i n gt h e recordedbloodpressures, which i s p l a c e d i n t h e s t u d y ' s d i r e c t o r y . The f i l e i s named w i t h t h e p a r t i c i p a n t I D as t h e f i l e name andbp as i t s e x t e n s i o n , i.e., X******.bp, where X r e p r e s e n t s t h e f i e l d center code,andtheasterisksrepresenttheparticipant I D number. ' 8.3.23 8.4 When t h e "Comments" s c r e e an p p e a r st,h seo n o g r a p h etry p ehs i s / h e r comments f o r t h e l e f t s i d e images,and p r e s s e s ENTER t o advance t h e program. Q u e s t iSocnr e e n s The sonographeruses Following "comments" i s a series of q u e s t i o ns c r e e n s . t h e ARROW key t o s e l e c t t h e a p p r o p r i a t e a n s w e r , a n d presses ENTER t o advance t o the next screen. 8.5 Ultrasound Conclusion Upon completion of t h e f i n a l q u e s t i o n s c r e e n , t h e p r o g r a ma u t o m a t i c a l l yc o p i e s a l l t h e p a r t i c i p a n t f i l e s from t h e h a r d d r i v e t o t h e d i s k e t t e . The s o n o g r a p h e ra p p l i e sl a b e l sa p p r o p r i a t e l y and f i l l s o u t t h e log a h e e t (See S e c t i o n 11). - 5 1/4" Copy t h eb l o o d pressure f i l e s o n t o a 5 114" f l o p p yd i s k e t t e .T h i s f l o p paynt d he 3 1/2" f l o p pcyo n t a i n i n g t h e p a r t i c i p a nf ti l e s ,h o u l d b e s e n t along w i t h t h e v i d e o t a p e t o t h e U l t r a s o u n d R e a d i n g C e n t e r . I n a d d i t i o n , a 5 1/4" f l o p p y c o n t a i n i n g a backupcopyof t h e b l o o dp r e s s u r e f i l e s s h o u l d be stored a t t h e f i e l d c e n t e r . ARIC PROTOCOL 6a.UltrasoundScanningProcedures - V i s i t 3 VERSION 3.0 01/95 66 RIGHT SIDE EXTERNAL 5 X cn INTERNAL TRANSVERSE LONGITUDINAL B-MODE IMAGE 3) 67 RIGHT SIDE 0-MODE IMAGE TRANSVERSE . LONGITUDINAL Figure 23. Right Carotid Artery - Transverse Scan Investigation Procedure - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 68 TRANSVERSE B=MBDE IMAGE I TRANSDUCE8 H U D 90' LONGITUDINAL Figure 24. . R i g h tC a r o t i dA r t e r y - T r a n s v e r s e Scan I n v e s t i g a t i o nP r o c e d u r e ARIC PROTOCOL 6a. U l t r a s o u n d Scanning Procedures - Visit 3 VERSION 3.0 01/95 69 RIGHT SIDE TRANSVERSE B-MODE IMAGE TRANSOUCER HWD 90° ~ LONGITWDtNAt Figure 2 5 . Right-CarotidArtery - Transverse Scan InvestigationProcedure ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - V i s i t 3 VERSION 3.0 01/95 70 LEFT SIDE I \ s EXTERNAL B=NIODE IMAG'E TRANSVERSE ROTATE . TRANSOUC€R HEAD 90° LONQITUDIHAL Figure 2 6 . L e f t ,CarotidArtery - TransverseScanInvestigationProcedure ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 71 LEFT SIDE B-MODE 1MAGE TRANSVERSE LONGiTUDINAL Figure 27. Left Carotid Artery - Transverse Scan Investigation Procedure 72 LEFT S I D E I B-MODE IMAGE LONQITUDINAL Figure 2 8 . Left Carotid Artery. - Transverse Scan Investigation Procedure AFtIC PROTOCOL 6a. U l t r a s o u n d S c a n n i n g P r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 . 73 LEFT S I D E I B=MODE IMAGE TRANSVERSE ROTATE TRANSOUCEa HEAD Figure 29. Left Carotid Artery - Transverse Scan Investigation Procedure - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 74 9. SONOGRAPHER TRAINING, CERTIFICATION 9.1 Training AND MONITORING The sonographer training program includes training sessions held the at respective field centers and the Ultrasound Reading Center, followed,by practice scans at the respective field centers and certification steps at the field centers. 9.1.1 Stage 1 During the initial weeks, a new sonographer works with the certified sonographers atthe field centerto observe the ultrasound area activities, become familiar with the equipment, read the introductory material supplied the URC, and become familiar with this scanning protocol. 9.1.2 Stage 2 The second phase (approximately 80 hours) at the Ultrasound Reading Center consists of lectures, demonstrations, and practical laboratory experience on the following topics: a. b. C. d. e. f. g* h. i. j. k. 1. Overview of the Study. Role of the Ultrasound Reading Center. Ultrasonic PhysicsI, including basic physics concepts, units of measurement, and mathematics arising in the medical applications of ultrasound. Overview of atherosclerosis and a detailed discussionthe of normal artery wall. Ultrasonic Physics2, including a discussion of the properties of ultrasonic waves, reflection at boundaries and scattering from small objects. Ultrasonic Physics 111, including the Doppler effect, ultrasound transducers and sound beams. Pathology of Atherosclerosis. Principles of Ultrasonic Instrumentation, including pulse-echo imaging systems, pulsed Doppler systems, and spectral analysis. Basic operationof the Biosound Phase2. Instrument Performance Monitoring. Basic Operation of the Custom Study Equipment Principles of Ultrasound Arterial Scanning. The remaining training time (at least 15 hours) at the field center will be spent practicing scanning technique on volunteers with the protocol, including the use of the study flow program and personal computer. The field center coordinator andthe chief sonographer need to help the novice sonographers in their recruitment and provide scheduled time for at one least volunteer practice scan per day. The chief sonographer determines when the new sonographer has attained sufficient skills to produce a scan according to this protocol. This portion of training is done under the direct supervision Of the chief sonographer who guides, evaluates, offers suggestions for improvements and answers questions as they arise. 9.1.3 Stage 3 ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 by 75 When t h e c h i e f s o n o g r a p h e r d e t e r m i n e s t h e new s o n o g r a p h e r i s r e a d y , t h e new aonographerscansvolunteerswith minimum s u p e r v i s i o n f r o m t h e chief s o n o g r a p h e r . When t h ec h i e fs o n o g r a p h e r has, reviewed 5 p r a c t i c e s c a n s t h a t comply w i t h t h e s t a n d a r d s o f q u a l i t y o f i n t e r f a c e s , i m a g e a l i g n m e n t , c u r s o r placement, i n t e r r o g a t i o n a n g l e s a n d o v e r a l l q u a l i t y o f s c a n n i n g , a n d t h e new a scan which conforms to sonogtapherhasdemonstratedthatshecanperform protocol w i t h i n t h e time a l l o t t e d by h e r f i e l d center f o r a n u l t r a s o u n d scan, thechiefsonographernotifiestheUltrasoundReadingCenterthatthe sonographerhascompletedthe p r a c t i c e phase. 9.1.4 Stage 4 Aftercompletionofthepracticephase,the new s o n o g r a p h e r p e r f o r m s n o more t h a n t w o scans per d a yo na d u l tv o l u n t e e r s . A t l e a s t t e n s c a n s are performed i n t h i s mode. A l l s u c h s t u d i e s are i d e n t i f i e d a n d s e n t t o t h e URC f o r t a p e s . The scans s u b j e c t e v a l u a t i o na l o n gw i t ht h en o r m a lw e e k l ys h i p m e n to f t o t h i s e v a l u a t i o n are scans f o r w h i c h t h e u l t r a s o u n d e q u i p m e n t is working properlyandstudyparticipantshave a r t e r i e s andanatomywhichpermit the walls t o be a d e q u a t e l yv i s u a l i z e d .T h e s es c a n s w i l l be e v a l u a t e d by t h e lead s t u d y sonographer ( o r h i s / h e r d e s i g n e e ) € o r e f f e c t i v e a d h e r e n c e t o p r o t o c o l . Duringthisstage,feedbackonthisprocess w i l l be given to the trainee. t o thestudystandards,thesonographer w i l l be When t e n s c a n s h a v e c o n f o r m e d c e r t i f i e d t o scan participants i n thisstudy,andhave.thedataresultingfrom thosescansenteredintothestudydatabase. 9.2 9.2.1 Certification C e r t i f i c a t i o n of Experienced Sonographers A aonographerattainscertification t o scanbaseduponherability,while following t h e ARIC/FHS s c a n n i n g p r o t o c o l , t o v i s u a l i z e a r t e r i a l walls consistentwiththeprocessaverageof a l l sonographers certified i n V i s i t s one”and t w o of ARIC, as i n d i c a t e d by p a i r e d p o i n t s m a r k e d by c e r t i f i e d readers a t t h eU l t r a s o u n dR e a d i n gC e n t e r . T h em o n t h l yr e v i e wo ft h es c a n ,b yt h el e a d s o n o g r a p h e ra n dc h i e fs o n o g r a p h e r , m u s t , onaverage, meet s c a n n i n gs t a n d a r d s . A s l o n g as a s o n o g r a p h e r m a i n t a i n s v i s u a l i z a t i o n c o n s i s t e n t w i t h t h e p r o c e s s a v e r a g e of h e r peers, a n d , t h e a v e r a g e o f m o n t h l y r e v i e w s c a n s meet p r o t o c o l s t a n d a r d s ,s h e retains certificatio;. ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 76 9.2.2 Certification ofNew Sonographers When the novice sonographer has successfully met all training requirements, as 9.1, written notification is sent to him/her and to the outlined in Section chief sonographer at his/her field center, informing the new sonographerof his/her new status as a certified sonographer. 9.2.3 Guest Sonographers During the course of this Study it is expected that, upon occasion, a sonographer willbe unavailable to scan participants without being able to give sufficient prior notice to allow for a reschedule of the participant's visit. If no provision were made for such an eventuality, participant's would be unduly inconvenienced, or may refuse to return to undergo an ultrasound evaluation. In such a case, in order to prevent a loss of valuable data, the services of a guest sonographer may be used. A guest sonographer isone who is well-versed in the applied principles of carotid ultrasound, and who is familiar withthe ARIC/FHS ultrasound scanning protocol and study equipment. The names and qualifications of guest sonographers areto be registered with . the Ultrasound Reading Center, where they will be ID assigned numbers. Prior to substituting for a certified sonographer for this Study, the guest sonographer isto re-read the protocol, and review it with the chief sonographer or, in her absence, another ARIC/FHS certified sonographer. Tapes containing scans recorded by the guest sonographer are to be clearly markedto that effect. Likewise, a notation is to be made on the log sheet. Upon receipt of these tapes at the Ultrasound Reading Center, these tapes the tapes produced by certified sonographers. They will first be reviewed by a certified reader. If the scans are found to conform to protocol, they will be logged in and treated from on in thenthe standard fashion. If, however, the scans are found not to conform to protocol, the scans will not be logged in and will not be read. The field center coordinator, chief sonographer and guest sonographer will be informed of the areas wherethe scan did not conform to the protocol. will not be logged in with Due to the additional effort required to process these scans, no guest sonographer may scan for more than five days or fifteen scans within two a month period without first obtaining speciai permission from the Executive Committee of this Study. Should a field center require additional sonographer support for an extended period, guest sonographers must undergo additional training as specified by the Ultrasound Reading Center in orderto become certified for this study. 9.2.4 Loss of Certification When a sonographer's average monthly boundary visualization falls significantly below the process average for one site, by a small amount for a number of sites, if the visualization report reveals any trend towardloss a of visualization, or if the scans produced deviate from protocol, theor, average monthly scans reviewed do not meet protocol standards, she and her chief sonographer will be notified of the specific nature and extent of loss of consistency so that remedial steps can be taken to improve visualization in those sites. 9.2.5 ' Scanning Process Control ARIC PROTOCOL 6a. Ultrasound Scanning Procedures- Visit 3 VERSION 3.0 01/95 77 The methods employed by the Ultrasound Reading Center for assuring the quality of ultrasound data are based on the work of F. Edwards Demming,J.M. Juran and Ellis Ott. Tools include process capability and statistical process control charting techniques, with consistent performance and constant improvement as goals. Timely feedback is critical to the successof this procedure. Therefore, on a routine basis, basedon frequency of scanning and sonographer consistency, sonographers will be given detailed reports of their performance, be and notified of the extent to which they conform to the quality and quantity of data gathering exhibited by the Study sonographers as a group. Below are indicated the steps to be followed basedon each sonographer's conformanceto these standards. 9.2.6 Conforming a 0 a 9.2..7 Non-conforming a a a a .. , a a 9.2.8 The sonographer, chief sonographer and study coordinator will receive written notification of her scanning performance. The sonographer will continue to scan. The URC will continueto monitor levels of visualization. a a slight The sonographer, chief sonographer and study coordinator will receive written notification of her scanning performance. The chief sonographer will check equipment performance and preventive maintenance record. The sonographer will review the scanning protocol the with chief sonographer. The chief sonographer will observe the sonographer perform that part of the scan which was found to conform not to standards. The sonographer will discuss with the chief sonographer to ways improve visualization at the specific site(s). The sonographer will report back to the URCon the steps taken to effect the improvement. The sonographer will continue to scan. The URC will continue to monitor levels of visualization. Non-conforming a - - moderate The sonographer, chief aonographer and study coordinator will receive written notification the of sonographer's scanning performance. The chief sonographer will check equipment performance and preventive maintenance record. The sonographer will review the scanning protocol with the chief sonographer. The sonographer will review training materials on the principles of physics and anatomy. The chief sonographer will observe the sonographer perform that part ofthe scan which was found notto conform to Standards. The lead study sonographer will identify patterns which might reveal the reason for failing to conform to the standard, document - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 78 0 0 0 9.2.9 areas in needof improvement, and communicate her findings to the sonographer. The sonographer and chief sonographer will discuss waysto improve visualization at the specific sites. The sonographer will practice that part ofthe scan on volunteers. The sonographer will report backto URC on steps takento effect improvement. The sonographer will continue to scan. The URC will continue to monitor levels of visualization. Non-conforming'- severe The sonographer, chief sonographer and study coordinator will receive written notification of the sonographer's scanning perform'ance. The sonographer willstop scanning cohort participants immediately. The chief sonographer will check equipment performance and preventive maintenance record. The lead study sonographer will identify patterns which might reveal the reason €or failing to conform to the standard, document areas in needof improvement, and communicate her findings to the sonographer. The sonographer will review training materials on the principles of physicsand anatomy. The sonographer will review the scan protocol the with chief sonographer. The chief sonographer will observe the sonographer as he/she performs that part of the scan which was found to conform not to standards. The sonographer andthe chief sonographer will discuss ways to improve visualization at those specific sites. The sonographer will produce a taped scan of a volunteer of cohort age. The sonographer will then make practice scans on volunteers. When the chief sonographer determines that sufficient improvement has been made, the sonographer will make another taped scan of the same initial volunteer. Both tapes will be sent to the UC for evaluation. The sonographer will report back to URC on steps she has taken to effect improvement. When the URC determines that improvement has been demonstrated, with visualization ator above the study average for all sites, the sonographer, chief sonographer and field center coordinator will be notified,and the sonographer may then resume scanning. The URC will continueto monitor levels of visualization. - Visit 3 VERSION 3.0 01/95 ARIC PROTOCOL 6a. Ultrasound Scanning Procedures 9.3 Monitoring Sonographer performance is monitored throughout the Atherosclerosis Risk in Communities Study at the respective field centerstheandUltrasound Reading Center. 9.3.1 Monitoring at Field Center Each monththe chief sonographer reviews on0 scan per sonographer for hie/her field center. The primary purpose for review is to ensure the quality of the study data and adherenceto the scanning protocol. The B-mode images are evaluated for overall image quality, the presence and clarity of the arterial wall boundaries,and the presence of anatomical landmarks and a cursor indicating the location of an anatomical landmark the and vessellumen. The timeof the month for sonographer review for each sonographer is determined by the chief sonographer, but is not the same from month to month. All reviews are sent to the URC before and no later the thanend ofthe third week of that month. It is recommended by the Ultrasound Reading Center that only one review per week be performed to reduce the time commitment during any one week. The chief sonographer keeps a log the of review and discusses her findings withthe sonographer on a timely basis. 9.3.2 Monitoring at the Ultrasound Reading Center Sonographer performance is monitored at the Ultrasound Reading Center using a number of quality assurance procedures. The quality assurance procedures include but are not limited to:(1) comparing results of repeat studieson a randomly selected identical site and angle of individual participants; (2) periodic reports containing statistics of boundary visualization by individual sonographer and study wide; (3) visual review of randomly selected participant scans; ( 4 ) on-site monitoring of sonographer performance by designated URC .personnel. Reports are'generated and distributed by the Ultrasound Reading Center. In addition,the Ultrasound Reading Center can review the same participant studies reviewed bythe chief sonographers at the field centers.The sonographer evaluation form is completed atURC, theand the results are compared to the chief sonographer's form. Any significant differences between the chief evaluations, or any significant problems are discussed with sonographers to resolve thedifferences. Results of these sonographer evaluations are used to help maintain high standards for participant studies and are part of an ongoing sonographer recertification process. The Ultrasound Reading Center readers read the ultrasound images from all the data collection procedures and the quality assurance images. Image interpretation results from study images and quality assurance images from the same site and angle are compared for use in sonographer quality assurance procedures. The purpose of this evaluation procedure is to determine the, %consistencyand reproducibilityof scanning and of interpreting ultrasound images. The results of these evaluations are reported periodically to the ARIC Coordinating Center and the field centers. ARIC PROTOCOL 6a. - Ultrasound Scanning ProceduresVisit 3 VERSION 3.0 0 1 / 9 5 80 9.4 The E-Mode Study Scan Evaluation Form The current versionof the B-mode study scan evaluation formis on file at the Ultrasound Reading Center in Winston-Salem, NC. This form provides a forum f o r a detailed accounting of the conformance to scanning protocol as described in this document. 9.5 The Lead Study Sonographer The Ultrasound Reading Center is responsible €orpre-certification, certification and re-certification ofsonographers. Certifying processes involve the review and evaluation B-mode of scans, as well as statistical evaluation of sonographer performance. The lead study sonographer provides feedback to the sonographer, his/her chief sonographer toandthe Ultrasound Coordinator. This feedback to the sonographerincludes, but is not limited to, site visits, verbal communication over the phone or in form the of taped comments of reviewed scans, written communication, in the form of formal reviews of scans, statistical evaluations of performance and recertification reports. . ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 81 10. SUMMARY OF CHIEF SONWRAPHER DUTIES The c h i e f s o n o g r a p h e r s ' d u t i e s are a v i t a l p a r t o f m a i n t a i n i n g t h e q u a l i t y o f t h eu l t r a s o u n dd a t a a t t h e f i e l d c e n t e r s . The e s t i m a t e d t i m e - e f f o r t required, e x c l u s i v e of t r a i n i n g new sonographers, is 10 p e r c e n t . A summary o fd u t i e s is l i s t e d below. a. A s a i s t st h eU l t r a s o u n dR e a d i n gC e n t e ri nt r a i n i n g a s d e s c r i b e d i n S e c t i o n 9.1.3, S t a g e 3 . b. Responsible f orre v i e w i n gs o n o g r a p h esr c a n n i n gp e r f o r m a n c e i n S e c t i o n 9.3.1. C. Responsible f o r e v i e w i n gt h eq u a l i t ya s s u r a n c ed a t ap r e p a r e db yt h e U l t r a s o u n dR e a d i n gC e n t e rf o r t h e field center,andforeach are s o n o g r a p h e r a t t h a t f i e l d center. C u r r e n tv a l u e sa n dt r e n d s reviewed,and if problems arise, t h e c h i e f s o n o g r a p h e r a n d t h e Ultrasound Reading C e n t e r w i l l work t o g e t h e r w i t h t h e s o n o g r a p h e r i m p l e m e n ts o l u t i o n s . new s o n o g r a p h e r s to to d. R e s p o n s i b l ef o r e p o r t i n gu l t r a s o u n d the Ultrasound Reading Center. e. R e s p o n s i b l ef o sr c h e d u l i n gp r e v e n t i v em a i n t e n a n c ev i s i t as n do t h e r s e r v i c e c a l l s a s needed.Beforeeach v i s i t or c a l l t o Biosound, a l i s t of problems a r e w r i t t e n and given t o them, i n case s p e c i a l t e s t equipmentorboards are required. fR . e s p o n s i b l ef ocr o m m u n i c a t i o n g *R e s p o n s i b l e area equipment problems as d e s c r i b e d with the U l t r a s o u n dR e a d i n g for s o n o g r a p h er e c e r t i f i c a t i o n ARIC PROTOCOL 6a. UltrasoundScanningProcedures Center. as o u t l i n e di nS e c t i o n - Visit 9. 3 VERSION 3.0 0 1 / 9 5 82 11. LABELING AND MAILING TO THE ULTRASOUND READING CENTER 11.1 Labeling of Video Cassettes and Diskettes Video cassette and diskette labels identify the field center and are numbered sequentially. The starting number for each field center is listed below: Forsyth ARIC/FHS: Jackson ARIC: Minneapolis ARIC/FHS: Framingham FHS: Salt Lake City FHS: Hagerstown ARIC: FlOOOlX F20001X J30001X M50001X B60001X U80001X W70001X The final character, shown as an "X" here, is a code check character. Each field center maintains a log that records the video cassette number and the participant identification numbers on that cassette (Log sheet reference Appendix 5). The information in columns 1-10 must be included and filled out by sonographers before theysend it to the Ultrasound Reading Center. -- 11.1.1 Each video cassette is labeled with the video cassette number and no more than four participant identification numbers. Note that the video cassette number appears only once on the short edge the video cassette. The video cassette box is also labeled on the short edge. (See labeling diagram Appendix 6) - 11.1.2 Each diskette is labeled with the diskette number (which is identical to the video cassette number) and the participant identification numbers. The diskette is placed with its matching video cassette for shipping. (See labeling diagram Appendix 6) - 11.2 Content of Mailing Each weekly mailing from the field centers to contains: a. the Ultrasound Reading Center e. f. g- Video cassettes for the participant ultrasound studies completed the previous week. Diskettes containing the participant files for the ultrasound studies completed the previousweek. Diskettes containing the blood pressure files for the ultrasound studies completed the previous week. A copy of the week's log sheet. (See Appendix 5) A copy of the Shipping Log sheet for the week. A video cassette containing phantom scan(s), if appropriate. Biosound Service Report, if appropriate. 11.3 Frequency o f - Mailing b. C. C. The video cassettes, diskettes and lists described in Section 11.1 are mailed t o the Ultrasound ReadingCenter. each weekno later than Tuesday afternoon The Ultrasound Reading Center needsto receive these cassettes no later than Wednesday afternoon. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 of 11.4 PackageLabeling The address labelfrom each field centerhas the following information: a. b. C. d. Field center personnel sending the package. Fieldcenterreturn address. The shipping number from the Shipping Log sheet. Address label to the Ultrasound Reading Center: Ultrasound Reading Center 4310 Enterprise Drive, Suite C Winston-Salem, North Carolina 27106 Mailing is by services guaranteeing package arrival at the Ultrasound Reading Center no later than mid-afternoon on the Wednesday following the mailing. 11.5 Verification of Mailing Contents The contents areverified upon receipt of shipment at URC. discrepancies, the field center w i l l be notified. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures If there are any Visit 3 VERSION 3.0 01/95 a4 12. POLICIES/PROCEDURES FOR REPORTING B-MODE ULTRASOUND RESULTS 12.1 RoutineReporting 12.1.1 Routine Report by Field Center to Participant A clinic visit report is issued by the field center, informing the participant that an evaluation will be made of the ultrasound examination and that further notification will be made ONLY in the case of unusual findings. A sample letter appearsbelow. “Portions of the carotid arteries (blood vessels in the neck) measured. were We will contact you (and your physician) if the opening of an artery is narrowed t o 2 millimeters or less. 12.1.2 Routine Report from Ultrasound Reading Center t o Field Center The ultrasound reportt o each field centeris a weekly listof participant studies read the previous week andalert an designation whenever an alert condition was detectedat the Ultrasound ReadingCenter. The list will consist of the followinginformation: a. b. C. d. e. f.. Participant Identification numbers Participant last name, first and middle initial Dateofbirth Raceandgender Examination date Alert (Yes or Blank) 12.2 . Procedures for Non-routine Results 12.2.1 If lumen narrowing t o 2 mm or less is detected by the sonographer: The sonographer identifiesa study the log sheet. The URC identifies the URC ultrasound clinician. Such prior to the routine reading by URC 12.2.2 as a possible alert and notes the reason thestudy for review and confirmationby reviews take placeon a regular basis, readers. on If lumen narrowing t o 2 mm or less is detected by the reader: The study will proceed through the routine reading process. The reader identifies a study as a possible alert. The study is reviewed by the URC a regular basis. ultrasound clinician. Such reviews take place on 12.3.1 Report from Ultrasound Reading Center t o Field Center A report is sent by the URC to the field center listing all studies for which possible alerts were citedby the sonographer. This report will indicate which studies were and were not confirmed as alerts. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 85 12.3.2 Reporting of Confirmed Field Center Alerts by t h e U l t r a s o u n d R e a d i n gC e n t e r to URC c l i n i c i a n t o t h e f i e l d c e n t e r w i t h a brief e v a l u a t i o n .T h ef i e l dc e n t e rt h e nc o n t a c t st h ep a r t i c i p a n ta n dt h e care. The URC s e n d s a report summarizing p a r t i c i p a n t ' sp r o v i d e ro fm e d i c a l a n a b n o r m a l i t y was i d e n t i f i e d a n d , thefindingsoftheclinician,whether a clinicalevaluation. w h e r ea p p r o p r i a t e ,t os u g g e s t A report i s s e n t b y t h e 12.3.3 R e p o r t i n goC f onfirmed Participant Alerts by t h eF i e l dC e n t e r to the An examples o f a l e t t e r t o send t o t h e p a r t i c i p a n t s i n whom a c a r o t i d u l t r a s o u n d a l e r t v a l u e is confirmedappearbelow. Alert for lumennarrowing t o 2 mrn o r less: "As a p a r t i c i p a n t i n t h e ARIC Study,youhad a B-mode. u l t r a s o u n d e x a m i n a t i o n c a r o t i d a r t e r i e s ( b l o o dv e s s e l si ny o u rn e c k ) .D u r i n gt h a t was f o u n d i n t h e e x a m i n a t i o n ,n a r r o w i n g of t h e o f t h e v e s s e l a r t e r y ( s ) .S u c hn a r r o w i n g i s m o s to f t e na s s o c i a t e dw i t ha t h e r o s c l e r o s i s ( h a r d e n i n g of t h e a r t e r i e s ) . While some narrowing i s found i n many p e o p l e , t h e amount o f n a r r o w i n g i d e n t i f i e d onyourstudy was g r e a t e r t h a n e x p e c t e d ( r e s i d u a l lumenof 2 mm o r l e s s ) . W e recommend t h a t you c o n s u l t w i t h your physician t o determinewhetherfurtherevaluation or t r e a t m e n t i s n e c e s s a r y . If you do n o t have a p e r s o n a l p h y s i c i a n t h e ARIC o f f i c e w i l l be happy t o work w i t hy o u t o a r r a n g e f o r a r e f e r r a l . " t o m e a s u r et h e ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 VERSION 3.0 01/95 86 13 See PARTICIPANT SAFETY PRECAUTIONS Manual 2. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - V i s i t 3 VERSION 3.0 01/95 A - APPENDIX I: 1 DOPPLER SIGNAL IDENTIFICATION OF THE INTERNAL CAROTID ARTERY It is important t o carefully distinguish between the internal and external c a r o t i d arteries u s i n g two c r i t e r i a . F i r s t , t h e i n t e r n a l n o r m a l l y h a s a s i g n i f i c a n t l yl a r g e rd i a m e t e rt h a nt h ee x t e r n a l ;s e c o n d ,t h eb l o o df l o w is v e l o c i t y p a t t e r n i n t h e two v e s s e l s as d e t e r m i n e d w i t h D o p p l e r u l t r a s o u n d d i s t i n c t l yd i f f e r e n t . Used t o g e t h e r ,t h e s e two c o n s i d e r a t i o n s permit t h e i n t e r n a l c a r o t i d a r t e r y t o be i d e n t i f i e d w i t h a h i g h d e g r e e o f c o n f i d e n c e . Althoughtributariesoriginatingfromtheexternalcarotidartery may occasionallybeviewedwith B-mode u l t r a s o u n d t o h e l p i n t h i s d i f f e r e n t i a t i o n , D o p p l e ru l t r a s o u n di nm o s tc a s e s i s more e f f i c i e n t a n d s p e c i f i c f o r t h i s separation. Themethod and c r i t e r i a f o r t h i s i d e n t i f i c a t i o n are a s f o l l o w s : A B-mode image i s o b t a i n e d of t h e c a r o t i d b i f u r c a t i o n w h e r e t h e common c a r o t i d a r t e r yd i v i d e s . I n some instances, t h eb e s ta n a t o m i c a la n g l e w i l l show t h e arteries. f l o w d i v i d e r a s well as t h e p r o x i m a l i n t e r n a l a n d e x t e r n a l c a r o t i d I n t h e r e m a i n i n g cases, t h e f l o w d i v i d e r a n d o n l y o n e v e s s e l c a n b e s e e n f r o m a s i n g l ea n g l e .I nt h o s ei n s t a n c e s ,t h eo t h e ra r t e r yc a n be v i s u a l i z e d b y gentlyrockingtheultrasoundtransducerbackandforth i n angle or position or both.Doppler is u s e d t o d i f f e r e n t i a t e i n t e r n a l a n d e x t e r n a l c a r o t i d arteries i n t h e s e i n s t a n c e s . To o b t a i n a Doppler sample o f each a r t e r y , p r e s s t h e DOP CUR b u t t o n o n t h e instrumentpanelandusing the tracking ball on the instrument panel move t h e Doppler c u r s o r so t h a t it i s p o s i t i o n e d w i t h i n t h e lumen o f t h e b r a n c h f a r t h e s tf r o mt h es k i n surface. The DOP b u t t o n i s p r e s s e d . Thesonographer t o t h e Doppler s i g n a l by observes the tracing on the left monitor and listens t u r n i n gu pt h ea u d i oo nt h ei n s t r u m e n tp a n e l .I ft h eu l t r a s o u n dt r a n s d u c e r is i n t h e i n t e r n a l carotid a r t e r y , t h e f l o w p a t t e r n w i l l be t h a t o f a l o w r e s i s t a n c eb e d .T h i ss i g n a lh a s a r a p i du p s t r o k e and a q u a s i - s t e a d yf l o w The f l o wc o n t i n u e st h r o u g h o u tt h e cardiac c y c l e t h r o u g hs y s t o l ea n dd i a s t o l e . and b e g i n s t o i n c r e a s e a g a i n a t t h e n e x t s y s t o l e . away from t h e h e a r t t h r o u g h o u t t h e c y c l e is Flow directed t o w a r d t h e h e a d a n d r e p r e s e n t e d a s a t r a c i n ga b o v e t h e b a s e l i n ei nF i g u r e 15. I ft h eD o p p l e r s i g n a l d o e s not correspond t o theexpectedpattern, t h e cursor is placed of t h e common c a r o t i d a r t e r y . The e x t e r n a l c a r o t i d w i t h i nt h eo t h e rb r a n c h a r t e r y is u s u a l l y n e a r e r t h e s k i n s u r f a c e when viewedfrom a n a n t e r i o r a n g l e and i s a h i g h - r e s i s t a n c ev e s s e l . The c h a r a c t e r i s t i c s of D o p p l e rs i g n a l i n t h i s v e s s e l are a f o r w a r d f l o w w i t h a s h a r pu p s t r o k ea n ds o m e t i m e s a highr e s i s t a n c e a r t e r y is cessationofflowbeforetheonsetofthenextsystole as d e f i n e di nF i g u r e 16. A D o p p l e rs i g n a lf o r a c o m b i n a t i o no fi n t e r n a la n d e x t e r n a l carotid f l o wp a t t e r n s is i l l u s t r a t e d i n Figure 17. T h e e x t e n t t o whichtheDoppler e f f e c t "occurs" depends upon the relative t h e direction of propagation of orientation of the direction of blood flow and are p a r a l l e l , t h e e f f e c t is t h eu l t r a s o u n dp u l s e .I ft h et w od i r e c t i o n s maximum. I f t h e d i r e c t i o n s are p e r p e n d i c u l a r ,i np r i n c i p l e NO DOPPLER EFFECT WILL OCCUR. While it i s i m p o s s i b l e g e t t h e d i r e c t i o n s o f u l t r a s o u n d p r o p a g a t i o n and b l o o d a s c l o s e t o p a r a l l e l a s possible i n f l o w e x a c t l y p a r a l l e l , t h e ys h o u l db e o r d e r t o o b t a i n a s t r o n gD o p p l e rs i g n a l .R e g a r d l e s so fw h e t h e rt h e a i d e l o o k i n g or i n l i n e D o p p l e r f u n c t i o n s are u s e d , t h e two d i r e c t i o n s m u s t NOT BE PERPENDICULAR. ARIC PROTOCOL 6a.UltrasoundScanningProcedures - V i s i t 3 VERSION 3.0 01/95 A - 2 APPENDIX 11: SOFTWARE TROUBLESHOOTING Common Problems and Their Solutions Listed below are some problems you could encounter, and some suggestions on how t o correct them. At the C:> prompt, type aricscan and press the ENTER key. The message badcommand or file name indicates entered. Correct the spellingand try again. that an incorrect command was C: >Date If the correct date appears, press the ENTER key. If the date die-played is' incorrect, type in thecorrect date using the exact format displayed on the computer screen. Example: 01-14-93 C :>Time If the correct timeappears, press the ENTERkey. If the displayed time is incorrect, type in the time of day using the exactformat displayed on the computer screen. Example: 10:30 Demographic screen entries: PartiCiDant ID: Six digits must be entered. If a digit is left off, it must be entered t o continue or backspacet o correct entire ID. Visit: Two digits must be entered. Example: 07 referring t o Visit 03. If one digit is entered, the computer waits for the second digit. SonoqrarJher: Three digits must beentered. If two or less digits are entered, you will not be able t o continue. If by accident a fourth digit is pressed, an ERROR screen appears. Press the ENTER key. The demographic screen reappears. Corrections can be made at this time by using the backspacekey. Cassette: The identification of the tape will automatically appear on the demographics screen. (the tapehas to be put in before this screen) Verify tape in VCR and screen ID'S match. Initials: Enter the participant's first and middle initials. If the participant has no middleinitial, enter the one initial and press ENTER. To insert a period for no initial press ENTER again. Once the period appears press ENTER againto move to the next field. If it is necessary to makea correction, use the left arrow key to return to the INITIALS column to make corrections. Last Name: Type.only thefirst five digits of the participant's last name and press the ENTERkey. No more than five digits will be recorded on file. Gender: Enter F or M. If a different letter is entered, an ERROR message appears. Press the ENTERkey and type in the correct entry. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures- Visit 3 VERSION 3.0 01/95 A - 3 Enter 8 , W or 0. If something different is entered, an ERROR message appears. Press the ENTER key and type in the correct entry. Race : Date Of Birth: Type in the participant's date of birth. If a nonexistent number of a month or day is entered, for example: 14/12/32, or 12/32/32, an ERROR message appears. Press the ENTER key and type in the correct date of.birth. Note: If an incorrect date of birth that a valid date is entered, the sonoarauher is resDonsible for correctingit at the verification screen. Note: The backspacekey can is pressed. be used to make corrections until the ENTER key Note: If you are at the end of the demographics screenand notice an incorrect entry, use the left arrow key to toggle back to make necessary corrections. Common Problems Associated With the the Scanning Screen: If the NEXT SITE footswitch is pressed instead of the SELECT footswitch for a particular site, the program will toggle forward. You can immediately correct for this by pressing the PREVIOUS SITE on sonographer's the box t o toggle back to the skipped site, and then tone theimage using the SELECTfoot switch. Accidently pressing the SELECT instead of NEXT SITE before pressing RECORD on the sonographer's box will cause thecomputer monitor to blink for 5 seconds. The study flow screen will return after the blinking stops. The screen will read "Press RECORD" on the sonographer's box. A WAIT message appears while the VCR isautomatically put into recordby the computer. Software appears tobe "Hung": - the scan can be When the software will not respond t o the input commands continued by following these steps: 1. fast forward thetapetothe end of recordedspace 2. press RECORD on the VCR key pad 3. verbally identify the SELECT and NEXT SITE segments on the tape 4. Note on loasheet for this tape to be re-striped. 5. Record answers to questions that would normally be on the US screens: Lesion Sonographer impression Distensibility Code Deviations in Protocol (i.e. B-mode, BP and Distensibility) Wait Screens: If the wait screen seems hung, it has a time out feature after 2 minutes the software will issue the command t o retry the procedure. A - "Rewind for 8 seconds and ENTER" message appears when the VCR and computer have. lost the addressand does not know what sectionof the tape it is at. Sometimes this step willhave to be repeated more than once. Be hRIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 A - 4 sure the rewind8 seconds starts with recorded space on thetape. counter will count backwards when rewinding in a recorded space. Pause & Record mode The onVCR: If VCR is in the PAUSE& RECORD mode and does not release toRECORD only, press the PAUSEkey on theVCR key pad to releaseit manually. The program will then proceed through the flow of the scanning program. The VCR will then go into RECORD and you can continue with the scan. Comment Screen l a m e a r s huna): If the screenis blank with no"COMMENTS" heading, the sonographer should enter the comments and press ENTER to continue through the program. To Check HeaderFile: To change directory to ARIC at the c : > type cd(space)ARIC <ENTER> At C:\ARIC> type(space)header and 2 four digit f ' s will be displayed. The first four digits are the tape number and should match the tape being used; or, if a new tape is to be used the # should be one less than the new tape number. If the t a w number matches the tape beins used no edit is needed. At the C:\ARIC> type cd(space)\ <ENTER> to return to the root directory. Begin new scan. . .. If the tape number does not match the tape beins used do the following: At the,C:\ARIC> type edit(space)header <ENTER>. A menu dr.iven program will display thefile. Use the arrow keys to move the cursor to the tape number. Insert the correct number and .delete the old numberby using the deletekey. - When chanses are completed press Alt(key)+ F(key) t o get the file menu. Press X t o exit. A gray menu box will appear and ask if the changes are t o b e saved. Press Y and <ENTER>. This will return you to the C:\ARIC>. Type cd(space)\ <ENTER>. Begin new scan. Select liaht is on at the besinnins of a scan: If the Select light is on at the beginning of a scan, it must be reset before that scan can be performed. To reset the select lisht At the C : \ > type cd(space)test <ENTER>. At C:\TEST> type initff <ENTER>. This will cause the selectlight to go off. Then, at C:\TEST> type cd(space)\<ENTER> to return to the root directory of the computer. - ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 A - APPENDIX 111: 5 TROUBLESHOOTING Phase 2 Setup The i n s t r u c t i o n s o n t h e P h a s e 2 rightmonitorsuggeststhatanykeycan be pressed t o d i s p l a yt h em a i n menu. However, i f t h e l e t t e r "D" is n o t pressed a t tfiat p o i n t , t h e P h a s e 2 c a n n o t be placed i n debug mode w i t h o u t f i r s t i s n e c e s s a r y ,f o l l o w s h u t t i n g down a l l of t h ee q u i p m e n t .I fs h u t d o w n instructions in Section 6 t o startuptheequipment. I f t h e PROBE 2 key i s p r e s s e d , a No Probemessage key t o c o n t i n u e . appears. Press t h e PROBE 1 If a wrong menu key i s p r e s s e d , press t h e ESCAPE k e y , l o c a t e d o n t h e P h a s e keyboard, t o r e t u r n t o t h e p r e v i o u s menu. A t any time d u r i n g t h e s e t u p , I.D. is i n c o r r e c t , p r e s s t h e 2 it i s d i s c o v e r e d t h a t t h e p a r t i c i p a n t ' s name o r menu s c r e e n r e t u r n s . Press t h e 4 t h menu key t o d i s p l a y S e t u p . Press t h e f i r s t menu k e y f o r P a t i e n t menu. Press t h e f i r s t o r second menu key t o c o r r e c t t h e p a t i e n t i n f o r m a t i o n . menu, t h e CLEAR k e y ,l o c a t e d on t h e Once i n t h e N a m e o r P a r t i c i p a n t I . D . Phase 2 keyboard,can b e u s e d t o clear a n i n c o r r e c t e n t r y . ESCAPE k e y u n t i l t h e m a i n Remember t h a t t h e DOP CURSOR key i s u s e d as a t o g g l e . t h e c u r s o r a t a n y g i v e n time. I t canremove or r e t u r n - If the Dopplerdoesn't work well c h e c k c u r s o r a l i g n m e n t w i t h blood flow (see Appendix I ) and t h e f o c u ss e t t i n g . . I t s h o u l d be a l i g n e d t o t h e c u r s o r a r t e r y .C h e c kf o rB u b b l e si nt r a n s d u c e r .F o c u sa n d b u b b l e s i nt h et r a n s d u c e r sreatlv a f f e c t b o t h D o p p l e r a n d D i s t e n s i b i l i t y . - TO ensure that the image orientation i s in "standard" mode, t h e f o l l o w i n g s h o u l d be completed d a i l y : Select Imaae C o n t r o l m t i o n s Select Select S t a n d a r d Press ESCAPE t o e x i t o u t t o Main Menu Intheeventthattheequipment s t i l l f a i l s t o o p e r a t e as d e s i g n e d , c a l l theBiosoundtechnicianforassistance. ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - Visit 3 VERSION 3.0 0 1 / 9 5 A - 6 APPENDIX IVr BIOSOUND KEYBOARD ARIC PROTOCOL 6a. Ultrasound S c a n n i n g Procedures - Visit 3 VERSION 3.0 01/95 A - 7 APPENDIX Vr +A LOG SHEET REFERENCE For field center u s e t o r e c o r d e v a l u a t i o n r e c o r d / n o t i c e e f r o m t h e URC +B P l a c e cassette I D l a b e l h e r e +C P a r t i c i p a n t ID# 4D Participant date of birth +E P a r t i c i p a n t ' s l a s t name, f i r s t i n i t i a l , t h e n m i d d l e +F Record a c t u a l s c a n d a t e +G VCR s t a r t time * VCR s t o p time o n l yn e e d st ob er e c o r d e d (mm/dd/yy) participant on the tape +H initial Sonographer I D # Sonographer Impression: P F G E when t h e l a s t i s scanned. - Poor - Fair - Good - Excellent +I L i s t QC s i t e scanned +J L i s t t r a c k i n gi m p r e s s i o n .I fn ot r a c k i n g +K Yes/No. +L Any i n f o r m a t i o n p e r t i n e n t t o i n t e r p r e t a t i o n o f i m a g e s ox followingflowofscan,equipmentproblems, or imagingproblem, etc. + i s done, l i s t r e a s o n . L i s t sites notcompleted. RepeatCodes - 1. A c t u a l r e p e a t s c a n s o f thelogsheetonly. 2. a s i t e need t o b e i d e n t i f i e d on I f a code is r e p e a t e d b e c a u s e t h e select footswitch was n o t p r e s s e d t o a d v a n c e t h e f l o w c h a r t , n o t e o n t h e l o g s h e e tt h e circumstances. The s i t e s d on o t need t o b er e p e a t e d . Once i d e n t i f i e d ,t h e URC w i l l c o r r e c t t h e f i l e t o match t h e i m a g e s o n t a p e . S t a r t i n g Date andShipping ,Beginning Shipping follows: Number Numbers f o r e a c h f i e l d c e n t e r F o r s y t h ARIC/FHS: J a c k s o n ARIC: Minneapolis A R I C / F H S : are as FU3001 JU3001 Mu3001 ARIC PROTOCOL 6a.UltrasoundScanningProcedures - Visit 3 VERSION 3.0 0 1 / 9 5 A - 8 Hagerstown AFiIC: WU3001 - Loginreport t o FieldCenter t h i s report a c k n o w l e d g e s t h e is completefortheLogin receiptofstudiesandprocessing p r o c e d u r e sT . his report is s e n w t eekly. T h e s o n o g r a p h e r sc a n delete t h e s t u d i e s ' l i s t e d from t h e s t u d i e s d i r e c t o r y on t h e i r PC. Thisneeds. t o bedoneweekly t o p r e v e n th a r dd r i v ed i s k space problems. ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s - V i s i t 3 V E R S I O N 3.0 01/95 A - 9 LOQ SHEET -W +N ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n g h Procedures - Visit 3 VERSION 3 . 0 0 1 / 9 5 I PLACE CASSETTE ImlEN AND or I OEIS LABEL I - l l , ,?dl -IL. SUPER VIiS CASSETTE LABELING 1 CASSETTE LABEL DlllECflON LABELS 10 rACE (I) 4 / PLACE CASSETTE & PAnTICIPANT ’*- 0 “ _ TOP I-IEnE..PAnTICIFANTS I N SAME onoEn AS O N CASSETTE ,,- BOTTOM QOES INTO DISK D n w TtllS SIDE UP 3 112 INCH DISK LABELING ARIC PROTOCOL 6a. Ultrasound Scanning Procedures , ~ .., . ... . , , - Visit 3 VERSION 3.0 01/95 A - 10 APPENDIX VI: VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM V "_ Super VtIS ._". -SVtI! _.."_ cIc9E. 11119 1 SIM Or CASE LABEL i SUPER VHS CASSETTE LABELING > I I CASSETTE LABEL _- f . PLACE CASSETTE L PAl7TICIPANT LABELS , I4El7E..PAnTICIFANTS 4- TOP IN SAME o n m n AS ON CASSETTE \ f- BOTTOM QOES INTO DISKDnwE TttlS SIDE UP 3 1/2 INCH DISK LABELING - ARIC PROTOCOL 6a. Ultrasound'scanning Procedures Visit 3 VERSION 3.0 01/95 A - 11 T O P ARIC PROTOCOL 6a. Ultrasound'Scanning Procedures - Visit 3 VERSION 3.0 01/95 A - 12 APPENDIX VI18 WEEKLY SHIPPING LOG WEEKLY SHIPPING LOG SBIPPIXG LOG ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3,O 0 1 / 9 5 A APPENDIX VIII: I. - 13 INFORMATION REFERENCE SHEET List of contact personnel when experiencina eauipment or procedure failure durina the ultrasound scan. Before contacting the individual by phone, make a list of the apecific symptom, include the datesymptom started and date service problem was requested. Fax this list to your contact person and fax a copy t o the URC attention Delilah Cook, Chief Reader and Carolyn Bell login. Follow-up o n service by sending a summary of results by computer network mail, U.S. mail, or fax (preference of the field center) to URC -- - . 1. Biosound Fax # 317-841-8616 800-428-7378 Phase 2 Unit a Bob Nitch Dave Struewing Mike Meador 2. URC Fax # 919-759-2139 919-759-2137 - Peripheal Equipment Sonographer box, attached foot switches and cables, ultrasound software, the arterial tracker and transducer arm (at centers where applicable). Sonographer certification and training, and data flow Kathy Joyce, Administrative Secretary who will direct call asfollows: - Delilah Cook Protocol procedure, Sonographer Training and Data Flow, or equipment problems Carolyn Bell Login and Distensibility Pam Wells or Delilah Cook Sonographer Certification and Review -- 3. - Dell Computers Damian Brown 800-284-1200 or ext. 3967 local compouter repair facility 4. Dinamap Johnson & Johnson Critikon Pam Thornbury 800-255-2500 or 919-852-2733 5. Oscilloscope Tektronix 700 Professional Drive Gathersburg, Maryland 20879 6. Strip Chart Recorder ARIC PROTOCOL 6a. Ultrasound MFE Instruments John Lepore 800-472-4633 Fax # 508-921-9110 - Scanning Procedures Visit 3 VERSION 3.0 01/95 11. Miscellaneous EsuiDment Information -- 1. Dinamap calibration and alarm settings are Pre-set at the factory and do not need any action from the sonographer factory settings are acceptable for our purpose. 2. S-VHS tape -- - Do not purchase "Sony" brand tapes because the NEC-VCR is very sensitive and does not operate properly with this brand. Due to storage limitationat the URC, the Fuji tape has been tested and is recommended for this study. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 A APPENDIX IX: "The - 15 READING LIST Language of Anatomy" From: Gardner, W.D. & Osburn, W. A. (1973) Structureof the Humaq Bodv. (2nd ed.) Philadelphia: W.B. Saunders Company. "Angiology" From: Williams, P.L. and Warwick, R., eds. (1980) Gray's Anatomv. (36th ed) Philadelphia: W.B. Saunders Co. "Blood Supplyto the Head and Neck" From: Fried, L.A. (1976) Anatomv of the Head, Neck, Face,and Jaws. Philadelphia: Lea f Febiger. "Systemic and Pulmonary Circulations" S.L., Woods, S.L., Sivarajan, E.S. and Halpenny. From:Underhill, Co. C.J., eds. (1982) Cardiac Nursinq. Philadelphia: J.B. Lippincott "Pathogenesis of Atherosclerosis" From: Cardiac Nursinq. "The Carotid Plaque" From: Robicsek, F. Ed. (1986) Extracranial Cerebrovascular Diasnosis and Manauement. NY: McMillan Publishing. Disease Diasnostic Ultrasound, Principles, Instruments, and Exercises by Frederick W. Kremkau, Ph.D. Third Edition Publisher: W. B. Saunders Company Harcourt Brace Jovanovich, Inc. Chapter 1 from Diasnostic Ultrasound; Frederick W. Kremkau, Ph.D. 3rd edition. Chapter 2, pages 9-30 in Diasnostic Ultrasound. Chapter 2, pages 41-45 of Diaunostic Ultrasound. Chapter 3of Diaunostic Ultrasound. Chapter 4 pages 105-114 and pages 130-137-of Diaunostic Ultrasound. "HOW a B-Mode Image is formed - A Summary". Chapter 5 in Diasnostic Ultrasound. Article, "Artifacts in Ultrasound Imaging" (Kremkau & Taylor) Chapter 6 in Diaunostic Ultrasound. Skip Section 6.3. Chapter 7 in Diaunostic Ultrasound. Skip Section 7.3. ARIC PROTOCOL 6a. - Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95 A - 16 Pignoli, P., Termoli, E., Poli, A., Oreste, P., Paoletti, R. (1986) "Intimal Plus Medial Thicknessof the Arterial Wall: A Direct Measurement with Ultrasound Imaging." Circulation. 74 (6), 1399-1406. Fact Sheet on Heart Attack, Stroke, and Risk Factors. (1987) American Heart Association. Dallas, TX. Pages 132-143 "Coronary Artery Disease Risk Factors" From: Cardiac Nursinq Coronary Risk Factor Statement to the American Public. (1987) American Heart Association. Dallas, TX. Grundy, S.M. (1986) Cholesterol and coronary heart (20) 2849-2858. Eron, Carol (1988) Young hearts. Science News. disease. JAMA. 256 134, 234-236. Stamler, J., Wentworth, D. t Neaton, J.D. (1986) "Is the Relationship Netween Serum Cholesterol and Risk of Premature Death From Coronary Heart Disease Continuous and Graded?" JAMA. 256 (20) 2823-2828. Enos, W.F., Holmes, R.H. & Beyer, J. (1953) "Coronary Heart Disease Among United States Soldiers Killedin Action in Korea: A Preliminary JAMA. 152, 1090-1093. (Reprinted 1986 JAMA 256 (20). Report." ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95 A - 17 "High ResolutionB-Mode Ultrasound Scanning Methodsin the Atherosclerosis Risk in Communities Study (ARIC)", M.G. Bond et al. Journal of Neuroimaging, Vol 1, No 2 , May 1991, pages 68-73. "High Resolution B-Mode Ultrasound Reading Methodsin the Atherosclerosis Risk in Communities (ARIC) Cohort, Ward A. Riley, et al. Journal of Neuroimaging, Vol 1, No 4 , November 1991, pages 168172. "An Approachto the Noninvasive Periodic Assessment of Arterial Elasticity in the Young"Riley, Barnes and Schey. Preventive Medicine 13, 169-184 (1984) "Ultrasonic Measurement of the Elastic Modulusof the Common Carotid Artery: The Atherosclerosis Risk in Communities (ARIC)Study". Accepted by Stroke, 1992. ARIC PROTOCOL 6a. Ultrasound Scanning Procedures - Visit 3 VERSION 3.0 01/95