ACRIN CV Committee

Imaging Procedures

Scott Akers, MD, PhD, RadiologistScott Akers, MD, PhD, RadiologistWalter Witschey, PhD, PhysicistWalter Witschey, PhD, PhysicistDena Flamini, RT (R) (MR), (M)Dena Flamini, RT (R) (MR), (M)

Imaging Analyst, ACRIN Core LabImaging Analyst, ACRIN Core Lab

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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

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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

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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

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Imaging Schema

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Imaging Forms

The following imaging forms should be completed in their entirety by the designated personnel for every submitted exam:

1. Image Transmittal Worksheet (ITW)2. 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

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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

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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

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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

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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

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Questions?Questions?