New Heart Imaging Techniques to Evaluate Possible Heart Disease

Recruiting now · Not applicable

Conditions studied: Healthy, Obesity, Diabetes, Healthy Volunteers, Atherosclerosis

In brief

Background: \- Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography. Objectives: \- To compare heart MRI techniques with other tests used to diagnose heart disease. Eligibility: \- People at least 18 years of age who either have or may have heart disease, or are healthy volunteers. Design: * Participants will be screened with a physical exam, medical history, and blood tests. * They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease. * Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan. * No treatment will be provided as part of this protocol.

Key facts

Study ID

NCT01399385

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

4000

Starts

2011-07-06

Expected to finish

2030-11-05

Last updated by the study team

2026-08-04

Who can join

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

You may not qualify if…

• Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
• Implanted cardiac pacemaker or defibrillator
• Cochlear Implants
• Ocular foreign body (e.g. metal shavings)
• Embedded shrapnel fragments
• Central nervous system aneurysm clips
• Implanted neural stimulator
• Medical infusion pumps
• Any implanted device that is incompatible with MRI.
• Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest.
• Subjects requiring sedation for MRI studies.
• Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
• Pregnant or lactating women.
• Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.
• Subjects who are unable to undergo a CTA within 2 months of the MRA part of this study, or are unable to undergo or be scheduled for a cardiac catheterization within 2 months of the MRA.
• EXCLUSION CRITERIA - FOR GADOLINIUM BASED MRI STUDIES ONLY:
• History of allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone.
• eGFR < 60 ml/min/1.73m\^2
• EXCLUSION CRITERIA - FOR CORONARY CTA:
• Contraindication to the use of CTA contrast agents:
• Creatinine value > 1.4 mg/dl
• History of multiple myeloma
• Use of metformin-containing products less than 24 hrs prior to contrast administration
• History of allergic reaction to CTA contrast agents despite the use of pre- medication with an anti-histaminic and cortisone.
• Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:

Where it is running

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

Full record on ClinicalTrials.gov

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