Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease

Completed

Conditions studied: Atherosclerosis, Hyperlipidemia, Hypertension, Diabetes Mellitus

In brief

This study will determine the usefulness of magnetic resonance imaging (MRI) for examining the heart or blood vessels. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. MRI of the heart and blood vessels, called magnetic resonance angiography (MRA), is a developing diagnostic method that permits evaluation of arteries and veins without the use of x-rays or invasive catheterization required by conventional angiography. People 18 years of age and older with known or suspected atherosclerotic disease may be eligible for this study. Participants have blood tests and MRA scanning. The MRA takes about 1.5 to 2 hours. During part of the scan, a contrast agent may be injected into a vein to brighten the images of the heart and blood vessels. Subjects are monitored with an electrocardiogram and are asked to hold their breath for about 5 to 20 seconds intermittently during the procedure. A CT scan may be done to confirm the MRA findings. CT uses x-rays to produce pictures of the heart and blood vessels. The subject lies on a bed during the scan and is given a contrast agent through a catheter inserted into a vein. Subjects are asked to hold their breath intermittently for about 5 to 20 seconds. A medicine called a beta blocker may be administered to slow the heart rate.

Key facts

Study ID

NCT00382564

Run by

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

People needed

216

Starts

2006-09-25

Expected to finish

2012-05-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not 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 1 month of the MRA part of this study, or are unable undergo or be scheduled for a cardiac catheterization within 1 month of the MRA.
• FOR GADOLINIUM BASED MRI STUDIES ONLY:
• History of severe allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone.
• Creatinine value greater than 3.0 mg/dl
• FOR CARDIAC CT:
• Recent cardiac CT within a month. Both a coronary CTA and calcium score scan are required for this study. If any of these scans were performed at an outside facility and meet the necessary quality level, then that aspect of the cardiac CT scan (coronary CTA, calcium score scan or both) will not be performed at the NIH. Coronary CTA and/or calcium score CT obtained at the outside facility must be performed within one month of subject inclusion and acquired using a 16 slice scanner or higher and should be of good quality. The unformatted images of outside cardiac scans must be available to the primary investigator within one month of their acquisition for eligibility of inclusion in the study.
• FOR CORONARY CTA:
• Contraindication to the use of CT contrast agents:
• Creatinine value greater than 1.4 mg/dl
• History of multiple myeloma
• Use of metformin-containing products less than 24 hrs prior to contrast administration

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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