search
Back to results

Study of Blood Flow in Heart Muscle

Primary Purpose

Coronary Disease, Healthy, Hypertrophic Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magnetic resonance imaging
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Gadolinium, Ischemia, Coronary Artery Disease, Hypertrophic Cardiomyopathy, Dipyridamole

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001631
Brief Title
Study of Blood Flow in Heart Muscle
Official Title
Study of Myocardial Perfusion by MRI
Study Type
Interventional

2. Study Status

Record Verification Date
January 2003
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Healthy, Hypertrophic Cardiomyopathy, Myocardial Ischemia
Keywords
Gadolinium, Ischemia, Coronary Artery Disease, Hypertrophic Cardiomyopathy, Dipyridamole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
249 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Magnetic resonance imaging

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8464365
Citation
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. doi: 10.1002/mrm.1910290410.
Results Reference
background
PubMed Identifier
8622587
Citation
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. doi: 10.1002/mrm.1910350214.
Results Reference
background
PubMed Identifier
7815687
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.
Results Reference
background

Learn more about this trial

Study of Blood Flow in Heart Muscle

We'll reach out to this number within 24 hrs