Blood flows to areas of the heart providing oxygen and fuel to the pumping muscle. Occasionally the arteries providing the fuel can become blocked. This occurs in coronary artery disease. Magnetic resonance imaging (MRI) can be used to evaluate the blood flow to different areas of the heart muscle. In this study magnetic resonance imaging will be compared to other diagnostic tests...
Date First Received: November 3, 1999
Last Updated: March 3, 2008
Verified by: National Institutes of Health Clinical Center (CC), January 2003
Clinical Trial Phase: Phase 2 | Start Date: August 1997
Overall Status: Completed
Estimated Enrollment: 249
Brief Summary
Official Title: “Study of Myocardial Perfusion by MRI”
Condition Keyword(s):
Intervention(s):
Blood flows to areas of the heart providing oxygen and fuel to the pumping muscle.
Occasionally the arteries providing the fuel can become blocked. This occurs in coronary artery disease.
Magnetic resonance imaging (MRI) can be used to evaluate the blood flow to different areas of the heart muscle. In this study magnetic resonance imaging will be compared to other diagnostic tests (radionucleotide perfusion studies) capable of measuring blood flow to heart muscle.
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Detailed Clinical Trial Description
In this pilot study, magnetic resonance imaging (MRI) of myocardial enhancement during first passage of intravenously injected gadolinium contrast will be used to evaluate regional myocardial perfusion in patients with known or suspected coronary artery disease and hypertrophic cardiomyopathy. The MRI results will be compared with conventional radionuclide perfusion studies (ex. dipyridamole thallium). A clinically defined normal group will also be studied without radionuclide correlation.
Intervention(s) in this Clinical Trial
- Procedure: Magnetic resonance imaging
Criteria for Participation in this Clinical Trial
INCLUSION CRITERIA:
- Ages 18 to 80.
- Either sex.
- Capable of giving informed consent.
- Group 1: Outpatients with known or suspected coronary artery disease with clinical indication for radionuclide perfusion imaging.
- Group 2: Patients with non-obstructive hypertrophic cardiomyopathy with clinical indication for radionuclide perfusion imaging.
- Group 3: Normal volunteers.
- Positive stress thallium or stress sestamibi (i.e., exercise, adenosine, dobutamine or dypiridamole) at the NIH.
EXCLUSION CRITERIA:
- Pregnancy.
- Unstable angina.
- Uncontrolled hypertension (SBP greater than 185, DBP greater than 105).
- Recent myocardial infarction (less than 5 days).
- 2nd or 3rd degree heart block by ECG.
- Asthma, emphysema, renal failure, acute medical illness (fever, pneumonia, etc.) or anemia (hct less than 30).
- Cardiac pacemaker or implantable defibrillator, aneurysm clip, neural stimulator, any type of ear implant, metal in your eye, any implanted device (i.e. insulin pump, drug infusion device) or any metallic foreign body, shrapnel, or bullet.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Related Publications
References
Wilke N, Simm C, Zhang J, Ellermann J, Ya X, Merkle H, Path G, Ludemann H, Bache RJ, Ugurbil K. Contrast-enhanced first pass myocardial perfusion imaging: correlation between myocardial blood flow in dogs at rest and during hyperemia. Magn Reson Med. 1993 Apr;29(4):485-97.
Matheijssen NA, Louwerenburg HW, van Rugge FP, Arens RP, Kauer B, de Roos A, van der Wall EE. Comparison of ultrafast dipyridamole magnetic resonance imaging with dipyridamole SestaMIBI SPECT for detection of perfusion abnormalities in patients with one-vessel coronary artery disease: assessment by quantitative model fitting. Magn Reson Med. 1996 Feb;35(2):221-8.
Zaman M, Hashmi R, Niaz K, Ahmad A, Kamal S. Safety of pharmacological (intravenous dipyridamole) stress for Thallium-201 perfusion imaging in patients with coronary artery disease unable to exercise. J Pak Med Assoc. 1994 Oct;44(10):237-9.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001631
Study ID Number: 970177
ClinicalTrials.gov Identifier: NCT00001631
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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