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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | August 1997 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001631 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| 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 Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Magnetic resonance imaging |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 249 |
| Completion Date | January 2003 |
| Primary Completion Date | |
| 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001631 |
| Responsible Party | |
| Study ID Numbers ICMJE | 970177, 97-H-0177 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | January 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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