Imaging Procedures

1. Imaging Procedures Scott Akers, MD, PhD, Radiologist Walter Witschey, PhD, Physicist Dena Flamini, RT (R) (MR), (M) Imaging Analyst, ACRIN Core Lab

2. Scanner Qualification • Each site must qualify by submitting volunteer MRI exam utilizing the ACRIN PA 4008 scanning protocol parameters- injection of Gadolinium is not necessary • The qualifying exam will be reviewed for image quality (e.g. artifacts, distortion, and signal-to-noise) and protocol compliance • An email will be sent to inform the site team of approval. In the event that the qualifying exam is not approved, required corrections for requalification will be included in the e-mail. • Please submit tonometry (.txt) qualification file at the same time for subsequent transmission to Dr. Chirinos for approval

3. Participant Scheduling • Participants will undergo two 1.5T cardiac MRI studies for the trial. • MRI SCAN 1: completed within (3) weeks prior to AVR • MRI Scan 2: completed (6) months post AVR

4. Participant Preparation • Standard practice for pre-treating severe claustrophobia or anxiety • eGFR must be >30 mL/min/1.73m² of body surface area. • Confirm participant has abstained from smoking, food, and alcohol for a minimum of four (4) hours • Confirm participant has abstained from caffeine-containing beverages for a minimum of 24 hours • If a short-acting nitrate was taken within four (4) hours prior to testing, the MRI scan will need to be rescheduled

5. Imaging Schema

6. Imaging Forms • The following imaging forms should be completed in their entirety by the designated personnel for every submitted exam: • Image Transmittal Worksheet (ITW) • MRI Assessment Form (MR) • It is recommended that each of the above forms be made available, in hard copy format, for the Imaging Technologists to be completed during image acquisition when the requested information on these forms is most readily available

7. Image Submission • Site should submit all ACRIN PA 4008 imaging to the ACR Imaging Core Lab in DICOM format via TRIAD. • All imaging should be submitted within 48 hours after acquisition • An Image Transmittal Worksheet (ITW) MUST be completed upon image submission

8. TRIAD • TRIAD (Transfer of Images and Data) is American College of Radiology Imaging Network’s image submission and management software • TRIAD-OA offers a web-based software solution which allows participating imaging sites a secure method to submit clinical trial images • TRIAD is remotely installed on a designated PC at your site • TRIAD software anonymizes, encrypts, and performs a lossless compression of the images before they are transferred to the ACRIN image archive • Frequently asked questions (FAQs) regarding TRIAD software can be found at https://triad.acr.org/faqs.htm

9. ACR Core Laboratory QC • Upon image receipt an ACRIN Imaging Technologist will: • Check for missing images/sequences • Appropriate image anonymization • Complete anatomical coverage of the heart • Adherence of all sequences to imaging protocol • Absence of image artifact • In cases where image sets are judged to be suboptimal the trial PI will be informed, and a replacement participant should be accrued

10. Image Data Queries • Any submitted exam which has missing data or does not follow the ACRIN PA 4008 protocol guidelines a Protocol Deviation form will be generated • Sites are expected to resolve data queries expeditiously • Queries not resolved within 7 business days will be sent to the ACRIN 6701 trial team for additional follow-up

11. Questions?