Study of Blood Flow in Heart Muscle

Healthy Clinical Trial

Official title:

Study of Myocardial Perfusion by MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001631
• Other study ID #: 970177
• Secondary ID: 97-H-0177
• Status: Completed
• Phase: Phase 2
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: August 1997
• Est. completion date: January 2003

Study information

• Verified date: January 2003
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: January 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Coronary Artery Disease
• Coronary Disease
• Healthy
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Myocardial Ischemia

Intervention

Procedure:
• Magnetic resonance imaging

Locations

Country	Name	City	State
United States	National Heart, Lung and Blood Institute (NHLBI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Wilke N, Simm C, Zhang J, Ellermann J, Ya X, Merkle H, Path G, Lüdemann 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. — View Citation

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. — View Citation