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Sponsored by: |
William Beaumont Hospitals |
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Information provided by: | William Beaumont Hospitals |
ClinicalTrials.gov Identifier: | NCT00541203 |
Coronary CT angiography (CCTA) offers great promise as a risk stratification tool in patients with suspected CAD.
It has been demonstrated in a multitude of accuracy studies to have a negative predictive value averaging over 95%. This leads to the hypothesis that a negative CCTA may preclude the need for invasive testing. The purpose of this randomized controlled study is to prospectively evaluate the role of CCTA on the management of patients with inconclusive or indeterminate stress test results.CCTA is able to provide not only information on presence and extent of coronary artery calcification, but detailed coronary anatomy as well.
SPECIFIC AIM # 1: To evaluate the diagnostic and prognostic performance of CCTA in patients with equivocal / intermediate stress test results as compared to conventional invasive coronary angiography.
SPECIFIC AIM # 2: To evaluate the utility of CCTA in prediction of major adverse cardiac events (MACE) compared to invasive coronary angiography at 30 days, 1 year, 3 years and 5 years.
Condition |
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Coronary Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Cardiac Computed Tomography In the Management of Patients With indeterminAte or inConclusive Stress Tests |
Estimated Enrollment: | 200 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2012 |
Outpatients scheduled to undergo cardiac catheterization and coronary angiography for the specific indication of inconclusive or indeterminate stress tests will be considered for this study. Patients will be initially screened by their cardiologist for the presence of inclusion/exclusion criteria, as well as pre-test and post-test likelihood of CAD.16, 17 All patients must have undergone a stress (exercise or pharmacologic) test within the past 3 months. After consent, patients will be randomized 1:1 to undergo CCTA or cardiac catheterization. The decision whether or not to proceed with subsequent invasive cardiac catheterization (CCTA arm) or revascularization (catheterization arm) will be made by the patient's primary and interventional cardiologists respectively.
Inclusion:
Exclusion:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Volunteers over 18 years of age; both genders; referred from participating cardiologist's offices
Inclusion Criteria:
Exclusion Criteria:
Contact: James M Wegner, BS | 248.898.3123 | jwegner@beaumont.edu |
Contact: Ann DePetris, RN,BSN,MSA | 248.551.6683 | ann.depetris@beaumont.edu |
United States, Michigan | |
William Beaumont Hospital | Recruiting |
Royal Oak, Michigan, United States, 48073 | |
Contact: James Wegner, BS 248-898-3123 jwegner@beaumont.edu | |
Contact: Ann DePetris, RN,BSN,MSA 248.551.6683 ann.depetris@beaumont.edu | |
Principal Investigator: Kavitha Chinnaiyan, MD |
Principal Investigator: | Kavitha Chinnaiyan, MD | William Beaumont Hospitals |
Study Director: | Gilbert Raff, MD | William Beaumont Hospitals |
Responsible Party: | William Beaumont Hopsital-Royal Oak, MI ( Gilbert Raff, MD- Director, Ministrelli Center for Advanced Cardiovascular Imaging ) |
Study ID Numbers: | 2007-120 |
Study First Received: | October 9, 2007 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00541203 History of Changes |
Health Authority: | United States: Institutional Review Board |
tomography coronary artery disease Stress Test Coronary Angiography |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Stress Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |