RecruitingNot Applicable

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

United States2,950 participantsStarted 2018-01-05

Plain-language 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

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

Currently healthy, self-reported

Exclusion criteria

When gadolinium based contrast agent (GBCA) exposure is planned
-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.
Important past medical illness
Subjects with CIED are excluded from conventional MRI unless they have CIEDs that are labeled as MRI conditional or MRI safe, and that are implanted greater than or equal to 4 weeks prior to MRI.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 72 months

Trial details

NCT IDNCT03331380

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-05-31

Contact for this trial

Anastasia Tsakirellis, C.R.N.P.

(301) 921-6986 anastasia.tsakirellis@nih.gov

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