Study of Blood Flow in Heart Muscle
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|ClinicalTrials.gov Identifier: NCT00001631|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
|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|
|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|
|Brief Title ICMJE||Study of Blood Flow in Heart Muscle|
|Official Title ICMJE||Study of Myocardial Perfusion by MRI|
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|
|Intervention ICMJE||Procedure: Magnetic resonance imaging|
|Study Arms ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||January 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Ages 18 to 80.
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.
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.
|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|
|NCT Number ICMJE||NCT00001631|
|Other Study ID Numbers ICMJE||970177
|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