Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease

NCT00382564 | Completed

• 2 other identifiers: 06024906-DK-0249
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis; Hyperlipidemia; Hypertension; Diabetes Mellitus

Keywords

Imaging; Arteriosclerosis; Hardening of the arteries; MRA; Narrowing of Vessels; Noninvasive Plaque Imaging; Atherosclerotic Disease; Plaque; Arteries; Diabetes; Hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CT or MRA), or Doppler ultrasound. Subjects at risk for atherosclerosis including: smoking, hyperlipidemia, low levels of high density lipoproteins (less than 50 mg/dl for women and less than 40 mg/dl for men), hypertension, family history (early onset atherosclerosis less than 55 year old in male and less than 65 year old in female who is first degree relative), and diabetes mellitus or metabolic syndrome.
• Subject must be willing to participate in the protocol.
• Subject age greater than 18 years old.
• Subject must be clinically stable and be able to come to the Clinical Center to participate in the study.

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kim WY, Danias PG, Stuber M, Flamm SD, Plein S, Nagel E, Langerak SE, Weber OM, Pedersen EM, Schmidt M, Botnar RM, Manning WJ. Coronary magnetic resonance angiography for the detection of coronary stenoses. N Engl J Med. 2001 Dec 27;345(26):1863-9. doi: 10.1056/NEJMoa010866.

  PMID: 11756576 BACKGROUND

• Lopez AD, Murray CC. The global burden of disease, 1990-2020. Nat Med. 1998 Nov;4(11):1241-3. doi: 10.1038/3218. No abstract available.

  PMID: 9809543 BACKGROUND

• Hoffmann MH, Shi H, Schmitz BL, Schmid FT, Lieberknecht M, Schulze R, Ludwig B, Kroschel U, Jahnke N, Haerer W, Brambs HJ, Aschoff AJ. Noninvasive coronary angiography with multislice computed tomography. JAMA. 2005 May 25;293(20):2471-8. doi: 10.1001/jama.293.20.2471.

  PMID: 15914747 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Hyperlipidemias; Hypertension; Diabetes Mellitus; Arteriosclerosis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed M Gharib, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 28, 2006
• First Posted: September 29, 2006
• Study Start: September 25, 2006
• Study Completion: May 1, 2012
• Last Updated: October 6, 2017

Record last verified: 2012-05-01

Locations

US (1)