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| Tracking Information | |||||||||
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| First Received Date † | February 20, 2009 | ||||||||
| Last Updated Date | February 24, 2009 | ||||||||
| Start Date † | October 2007 | ||||||||
| Current Primary Outcome Measures † |
To determine if a combined non-invasive cardiac imaging test (PET/CT) can determine coronary plaque severity, morphology and metabolic activity when compared to the gold standard of coronary angiography and intravascular ultrasound. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00850473 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | PET/CT Study in the Diagnosis of Coronary Plaque | ||||||||
| Official Title † | x Comparison of Cardiac Positron Emission Tomography/Computed Tomography (PET/CT) With Coronary Angiography (CA) in the Diagnosis and Characterization of Coronary Artery Plaque | ||||||||
| Brief Summary | This study is being done to determine if a picture taking test of the heart, positron emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in the heart arteries that lead to heart attacks when compared to the standard of heart catheterization. |
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| Detailed Description | Heart catheterization, in which a thin plastic tube, or catheter, is placed into an artery in the arm or leg and advanced into the heart arteries, is the procedure that you and your doctor have decided to pursue to look for heart artery blockages. It is being performed as part of your standard care and not for research purposes. The research procedure (cardiac PET/CT), which will be performed at a later date is a combination of heart CT (a test that involves the use of x-rays to identify heart artery blockages) and heart PET (an imaging test that uses a radioactive drug to look at how the heart uses fuel (sugar and fats) These tests will be combined (PET/CT) to look for the presence and type of blockage in your heart arteries. It is important to develop a test that can determine if and what type of blockage you have in your heart arteries as the presence and type of heart artery blockage is a very important predictor of heart attack and death from heart attack. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition † |
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| Intervention † |
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| Study Arms / Comparison Groups | Experimental: If enrolled in this study, the participant will have a PET/CT along with their Cardiac Catheterization to compare usability of images in diagnosis of heart vessel disease. | ||||||||
| 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 † | Recruiting | ||||||||
| Enrollment † | 100 | ||||||||
| Estimated Completion Date | October 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00850473 | ||||||||
| Responsible Party | Peter Rao, MD, Washington University School of Medicine | ||||||||
| Secondary IDs †† | 593F | ||||||||
| Study Sponsor † | Washington University School of Medicine | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | February 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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