INSTRUCTIONS FOR THE CAROTID MRI COMPLETION FORM, CMR, Version B, 12/08/2005

Transcription

1 INSTRUCTIONS FOR THE CAROTID MRI COMPLETION FORM, CMR, Version B, 12/08/2005 I. General Instructions: This form is used to document the conduct and completeness of the MRI examination. The MRI examination is a central component of the overall research protocol. The MRI scan should be conducted within two months of the Field Center visit and often will be done on the same day as this visit. Field Center Staff affix the participant ID label, name label and acrostic label (the last in item 0), fill out items 1 and 2 and pass the form to the MRI technician. The Field Center staff is also responsible for entering the form into the Data Entry System (DES). The MRI Technologist is to complete Items 3 12 at the time of the MRI exam either manually or using the MRI computer system. The completed form will be returned to the Field Center Staff within 24 hours (fax may be used). Field center staff will enter the data into DES within 24 hours upon receipt of the paper form. Whenever numerical responses are required, enter the number so that the last digit appears in the rightmost box. Enter leading zeroes where necessary to fill all boxes. If a number is entered incorrectly, mark through the incorrect entry with an X. Code the correct entry clearly above the incorrect entry. II. Specific Instructions: A. To Be Completed By Field Center Staff: 0. Apply the acrostic label to item Enter weight in pounds from the examination. Weight is recorded in Item 3 or Item 5 of the Anthropometry Form (ANT). 2. Circle the side selected by the Coordinating Center for detailed imaging (suspected side for plaque). This is the side shown on Item 17 of the Screening Form (CSC) which is based on the side with the thickest IMT that has not had carotid artery surgery. The AFU staff prints the screen from the Data Entry System for this Item and sends it to the Carotid MRI field center staff. B. To Be Completed by Radiology Technologist: 3a. Indicate whether it was safe for the participant to go through the MRI examination. If not, the participant became ineligible and MR imaging should not be performed for safety reasons. If not eligible, skip to Item 8 to document reasons that the participant was ineligible. 3b. Enter the date the MRI exam was performed. 4. Enter the series number in the left column and the number of images for that series in the right column. For example if series 1 has 4 images and there are 3 boxes in the left column followed MRI Completion Form QxQ (CMRB) Page 1 of 5

2 by 2 boxes on the right, it will be entered as series 001, # images 04. If the series wasn t done, it will be entered as 999 for the series number and 00 for the number of images in the series. Note: If an entire series needs to be repeated (e.g., the scanner malfunctioned, the subject continued to cough throughout the series, you noticed the wrong parameters were inadvertently entered for the scan, etc.), enter the series number and number of images only for the repeated series. 4.a. Record the series number and number of images for the scout series. For GE scanners, the Coronal and Axial scouts are separate series (i.e., items a and b, respectively). For the Siemens scanner, a 3-plane localizer is acquired and this series number is entered in a. 4.b.1. For GE scanners, an Asset Calibration must be acquired first and this series is recorded in item a. This image is used to optimize the parallel imaging capability of the coils. It looks like a cloud and isn t used for making measurements. 4.b.2. Carotid time of flight (TOF) MRA, enter the series number and number of images. 4.b.3. MIPs (TOF), enter the series number and number of images. 4.c.1. Oblique (black blood) DIR PD (Right), enter the series number and number of images (usually 3 images) 4.c.2. Oblique (black blood) DIR PD (Left), enter the series number and number of images (usually 3 images) 4.d.1. Axial (black blood) DIR T1 (Right CCA), enter the series number and number of images (usually 1 image) 4.d.2. For GE scanners write in the prescan values (R1, R2, TG, last 4 digits of AX, X, Y, and Z). These will be used for the postcontrast scan 4.m.1. For Siemens scanners leave this line blank. 4.e. Axial Multiecho (Right CCA), enter the series number and number of images (usually 4 images) 4.f.1. Axial (black blood) T1 DIR (Left CCA), enter the series number and number of images (usually 1 image) 4.f.2. For GE scanners write in the prescan values (R1, R2, TG, last 4 digits of AX, X, Y, and Z). These will be used for the postcontrast scan 4.m.2. For Siemens scanners leave this line blank. 4.g. Axial Multiecho (Left CCA), enter the series number and number of images (usually 4 images) 4.h.1. Circle the side selected to be imaged. This is usually the same side as indicated in item 2. Examine the TOF MRA and oblique black blood images (series 4.b-4.f) for the presence of plaque and carotid stenosis. Plaque usually forms along the outer wall of the internal carotid artery (ICA) opposite the flow divider but might occur higher in the ICA, or sometimes even just below the bifurcation. Be careful because flow artifact also occurs along the outer wall of the ICA but is usually less well-defined. Ignore plaque involving the external carotid artery. If no plaque is seen or if the stenosis is comparable on the two sides then image the side selected by the Coordinating Center. If a plaque is seen causing greater stenosis on the opposite side from MRI Completion Form QxQ (CMRB) Page 2 of 5

3 the side selected by the Coordinating Center (item 2) then change the selected side to the side with the greater stenosis. Please indicate your reason for the change. Examples of reasons for changing sides are: Left side selected by Coordinating Center (item 2) but: - Plaque causing stenosis is seen involving right ICA and none seen on the left side - Around 70% stenosis seen involving the right ICA but the stenosis on the left measures <50% 4.h.2. If no plaque was seen then enter a B in the box indicating that the bifurcation is imaged. If plaque was seen, enter a P in the box. 4.h.3 Enter the series number followed by the number of images for the PCMRA sequence. The side imaged is the side selected in 4.h.1. The images will be stored as two separate series for the Siemens scanner (i.e., phase and magnitude images), but as one series for the GE scanners. 4.h.4. Blood pressure recordings during the MRI are only obtained in centers that have equipment to do this (Wake Forest). The blood pressure should be timed during or close to the time of the PCMRA. All centers will measure blood pressure after the MRI. 4.i.1. Axial (black blood) DIR T1 (8 slices on bifurcation or plaque), enter the series number and number of images (usually 8 images) 4.i.2. For GE scanners enter the prescan values (R1, R2, TG, last 4 digits of AX, X, Y, and Z). These will be used for the postcontrast scan 4.m.3. For Siemens scanners leave this line blank. 4.j.1. Enter the image numbers for the two thickest contiguous slices selected from the 8 axial DIR T1 images. These should show the thickest cross-section of the plaque, or thickest carotid artery wall if no plaque is present. These 2 images will be reimaged in the subsequent multi-echo (ME) scan (4.j.2). 4.j.2-4.j.3. Enter the series number followed by the number of images for the two thickest slices scanned. For GE scanners, images from each slice will be stored as a separate series. For the Siemens scanner, both slices will be stored as one series. 4.k.1. Contrast enhanced MRA mask, enter the series number and number of images. 4.k.2. Record the exact time the contrast injection began. Circle AM or PM. 4.k.3. If the entire contrast dose was not successfully administered, circle N. Otherwise, circle Y and go to item 4.k.5. 4.k.4. Indicate the reason the entire contrast dose could not be administered. Examples: Nausea, injector malfunction, extravasation 4.k.5. Record the volume of contrast administered. If a complete dose was not given, estimate the volume successfully injected (e.g., based on remaining contrast in the syringe minus estimated extravasate if this occurred) and enter this number in the box. 4.k.6. Record the gadolinium lot number. MRI Completion Form QxQ (CMRB) Page 3 of 5

4 4.l.1. Coronal Gd-enhanced 3D MRA (10 sec after injection), enter the series number and number of images. 10 seconds is an approximation of the time it takes for the contrast to travel from the IV site to the carotids. Start the images 10 seconds after the injection begins. 4.l.2. Record the series number and number of images for the CEMRA MIPs. Do not construct these MIPs until after the 16 postcontrast axial T1 images are prescribed and/or scanning. 4.l.3. Wait exactly 5 minutes from the time the contrast administration began (recorded in 4.k.2) before starting the next sequence (4.m.1). 4.m.1. Repeat #4.d.1. Axial T1 DIR (Right CCA), enter the series number and number of images (usually 1 image). For GE scanners, use the pre-scan values entered in 4.d.2. 4.m.2. Repeat #4.f.1. Axial T1 DIR (Left CCA), enter the series number and number of images (usually 1 image). For GE scanners, use the pre-scan values entered in 4.f.2. 4.m.3. Repeat #4.i.1. Axial T1 DIR (16 slices on side selected), enter the series number and number of images (usually 16 images). For GE scanners, use the pre-scan values entered in 4.i.2. The 8 precontrast slices acquired in 4.i.1 will be repeated with 5 slices added above and 3 added below to make Enter the series numbers and number of images for the 4 Screen Saves. 5a. Oblique black blood image through right carotid used as a scout with slice position drawn for CCA 5b. Oblique black blood image through left carotid used as a scout with slice position drawn for CCA 5c. Obliqe black blood image through selected carotid used as a scout with slice positions drawn for precontrast T1 images through ICA/plaque 5d. Obliqe black blood image through selected carotid used as a scout with slice positions drawn for postcontrast T1 images through ICA/plaque 6. If one or more image needs to be repeated for some reason (e.g., motion artifact) but not the entire series, this section documents which images are repeated to help the Reading Center know which images are of the same location. In the left column, enter each series number that was repeated followed by the individual image numbers that were repeated. In the right column, enter the new series number followed by the number of images contained in this series. 7. Enter the BP (SBP/DBP) at the end of the study. The participant should be lying flat on his/her back for this measurement. In centers where automated blood pressure measurement is also done during the scan (Wake Forest) this recording should be taken using the automatic device approximately 1-5 minutes after the patient s head is out of the scanner. Note that blood pressure is not measured prior to the scan to allow the scan to start expediently and minimize the risk of a patient not being able to complete the scan. 8. If the MRI was completed, circle Y and go to item 9. Otherwise, circle N and continue with 8a. 8a. Indicate reason the MRI was not completed. 9. Enter the code for the MRI Technologist who performed this exam. MRI Completion Form QxQ (CMRB) Page 4 of 5

5 10. Enter any comments you have for the MRI Reading Center. This space can be used to elaborate on previous responses limited by boxes. 11. If the participant experienced a reaction to the contrast, please elaborate here. Examples: - Subject reported a mild headache which did not interfere with the scan - Subject reported difficulty breathing following administration of the contrast which required taking the subject out of the scanner and then evaluation was performed by Dr. X. 12. If you notice an abnormality on the scan which you think should be brought to a radiologist s attention such as a mass or a tight narrowing of the carotid artery, list the abnormality and notify the radiologist in your department. After the study is reviewed by the radiologist, enter his/her name. The Field Center should be notified immediately for urgent findings confirmed by the radiologist. C. Administratcion To Be Completed By Field Center Staff 13. Enter the date of data entry. 14. Enter the code number of staff entering the data into the Data Management System. MRI Completion Form QxQ (CMRB) Page 5 of 5