Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System

Not Applicable

Recruiting

• Conditions: CAD

• Registration Number: NCT03331380
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

Background:

Researchers are testing version of a system known as a magnetic resonance imagining (MRI) scanner that uses strong magnetic fields, radio waves and the like to create images of the organs in the body. It uses lower energy levels than other MRI scanners. This may help scan people with metal devices in their body, or in invasive heart procedures using metal tools.

Objective:

To test a new MRI scanner and software changes to create better pictures.

Eligibility:

People with disease and healthy volunteers, ages 18 and older.

Design:

Participants will be screened with blood tests.

Participants may have both the new MRI and a conventional MRI or only the new one. If 2 are done, they must be within 60 days.

For both MRI versions, participants lie on a table that slides into a large tube. During scans, they will hold their breath for up to 20 seconds at a time. Heart activity will be measured by wires connected to pads on the skin. A flexible belt may be used to monitor their breathing. They will be in the scanner up to 2 hours.

Participants can agree to have a dye called gadolinium injected into their arm during the scan. This brightens the pictures.

Participants can agree to take a drug called a vasodilator. This helps detect areas of the heart with abnormal blood supply. Scans of the heart are taken before, during, and after they get the medicine. The drug may cause temporary chest pain or shortness of breath. They may get other drugs to relieve these symptoms.

Sponsoring Institution: National Heart, Lung, and Blood Institute

Detailed Description

Cardiac magnetic resonance imaging (CMR) provides accurate and reproducible measures of cardiac chamber volumes, cardiac function, blood flow, myocardial scar, myocardial extracellular volume as a measure of collagen content, myocardial iron content, and others, all without exposure to ionizing radiation. The prevailing wisdom is that CMR using high specific absorption rate (SAR) scanning modes produces highest image quality. We propose a method of CMR, that can be performed with low SAR but that nevertheless preserves image quality because of efficient use of CMR signal. CMR using low SAR is attractive because it may reduce heating of metallic structures. This may allow safe CMR in patients with metallic implants, and it may allow MRI catheterization using metallic guidewires and catheter devices.

The goal of this non-significant risk (NSR) medical device study is to test initial technical feasibility of low SAR CMR in healthy volunteers by technical optimization of scanner protocols, to test comparative accuracy of standard CMR measurements in healthy volunteers using low SAR CMR versus conventional CMR, and to test comparative accuracy of standard CMR measurements in adult patients with known stable heart disease using low SAR CMR versus conventional CMR. A secondary goal is to assess the potential of this new low SAR CMR system to perform non cardiovascular radiological diagnostic imaging by testing comparative diagnostic accuracy of standard MR measurements in adult patients with known non cardiovascular disease using the low SAR CMR system vs conventional MR exam.

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-06
• Study Start: 2018-01-05
• Status Verified: 2025-07-08
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-10
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2850

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Technical feasibility and Non-inferiority of the above measurements and examinations ob-tained using low SAR CMR versus commercial CMR in healthy volun-teers and in patients with heart disease	72 months	To determine whether the the low SAR CMR is a feasible alternative to standard CMR

Secondary Outcome Measures

Name	Time	Method
Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states	60 months

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States