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Study of Blood Flow in Heart Muscle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001631
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date  ICMJE November 3, 1999
First Posted Date  ICMJE November 4, 1999
Last Update Posted Date March 4, 2008
Study Start Date  ICMJE August 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Blood Flow in Heart Muscle
Official Title  ICMJE Study of Myocardial Perfusion by MRI
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Disease
  • Healthy
  • Hypertrophic Cardiomyopathy
  • Myocardial Ischemia
Intervention  ICMJE Procedure: Magnetic resonance imaging
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
249
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00001631
Other Study ID Numbers  ICMJE 970177
97-H-0177
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP