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

Recruiting now · Not applicable

Conditions studied: CAD

In brief

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

Key facts

Study ID

NCT03331380

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

2950

Starts

2018-01-05

Expected to finish

2028-05-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Exclusion Criteria for All Participants:
• Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:
• Cerebral aneurysm clip unless it is labeled safe for MRI
• Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
• Any type of ear implant unless it is labeled safe for MRI
• Ocular foreign body (e.g. metal shavings)
• Metal shrapnel or bullet
• Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
• Pregnancy. When uncertain, subjects will undergo either urine or serum pregnancy testing. Results from up to 3 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.
• If a urine or serum pregnancy test was administered as part of a referral protocol, and the test was administered up to 3 days prior to MRI examination for this protocol, a new pregnancy test will not be required for this protocol.
• If a pregnancy test has not been administered within 3 days of MRI examination for this protocol, a serum or urine pregnancy test will be administered. Medical personnel will determine which pregnancy test is appropriate based on subject s medical history, screening, and individual scenario. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative.
• Exclusion Criteria for Gadolinium:
• When gadolinium based contrast agent (GBCA) exposure is planned
• Objective 1 and 2, Healthy Volunteers: No gadolinium based contrast agent exposure is permitted if eGFR < 60 mL/min/1.73m\^(2) using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications.
• Objective 3 and 4, Volunteers with Cardiac and Non-Cardiac Disease: No gadolinium based contrast agent exposure is permitted if eGFR < 30 mL/min/1.73m\^(2) using the CKDEPI equation [25] or equivalent and a serum creatinine measured within 2 weeks without
• intercurrent change in medical condition or medications.
• -For all objectives not more than two research MRI exams with GBCA exposure in a 12 month period. Research MRI exams performed outside of this protocol will be included in the 12 month period.
• Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents
• Breast feeding (unless subject is willing to discard breast milk for 24 hours)
• Does not wish to be exposed to gadolinium.
• Exclusion Criteria for Oxygen Inhalation:
• Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring
• Prior treatment with bleomycin
• Exclusion Criteria for Ferumoxytol Contrast
• A history of allergic reaction to any intravenous iron product

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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