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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | July 23, 2009 | ||||||||
| Start Date ICMJE | September 1997 | ||||||||
| Estimated Primary Completion Date | September 2000 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00001638 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Magnetic Resonance Imaging of the Blood Vessels of the Heart | ||||||||
| Official Title ICMJE | Cardiovascular Magnetic Resonance Imaging | ||||||||
| Brief Summary | This study is directed at evaluating patients with "myocardial ischemia" or poor blood supply to the heart muscle due to coronary artery disease. The major objective of this study is to determine the level of safety and effectiveness of magnetic resonance imaging at diagnosing coronary artery disease. In addition, this study will allow researchers at the National Institutes of Health to see a broad spectrum of disease, preserve clinical skills, and stimulate future ideas for clinical research.... |
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| Detailed Description | This is a teaching protocol. It is in a format for training physicians in the laboratory in cardiovascular MRI techniques necessary for our research protocols. It helps provide experience necessary to develop and maintain our clinical expertise with cardiovascular MRI methods. It also provides physicians in the region access to this technology. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Heart Disease | ||||||||
| Intervention ICMJE | |||||||||
| 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 | Recruiting | ||||||||
| Enrollment ICMJE | 99999999 | ||||||||
| Estimated Completion Date | September 2000 | ||||||||
| Estimated Primary Completion Date | September 2000 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria for All Arms of the Protocol
Exclusion Criteria for All Arms of the Protocol: Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
In addition the following patient groups will be excluded:
Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents:
The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to patients with acute renal insufficiency: eGFR (ml/min/l.73 m(2))= 175 x (serum creatinine)-l.l54 x (age)-0.203 x 0.742 (if the subject is female) x 1.212 (if the subject is black) Additional Exclusion Criteria for Dobutamine MRI
Additional Exclusion Criteria for Vasodilator Stress MRI
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001638 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 970204, 97-H-0204 | ||||||||
| 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 | August 2008 | ||||||||
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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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