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Sponsored by: |
VA Connecticut Healthcare System |
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Information provided by: | VA Connecticut Healthcare System |
ClinicalTrials.gov Identifier: | NCT00273819 |
The purpose of this study is to test the ability of a new X-ray technique called CT angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram.
Condition | Intervention |
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Congestive Heart Failure |
Procedure: CT angiography |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Single Blind, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Non-Invasive Detection of Revascularizable Cardiomyopathy |
Estimated Enrollment: | 30 |
Study Start Date: | October 2005 |
Study Completion Date: | June 2007 |
Objective:
In patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography. This procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality. With the advent of multidectector row-computed tomography technology, it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity. The goal of this study is to compare non-invasive computed tomography (CT) angiography with traditional coronary angiography to identify proximal, and hence revascularizable, coronary artery disease in patients with cardiomyopathy. Revascularizable is defined a 3 vessel proximal disease, left main disease, or left main equivalent disease (ostial left anterior descending and ostial left circumflex).
Research Design:
This study is prospective, interventional, single site with the interpreting radiologists blinded to the results from previous angiography.
Methods:
Subjects will be patients with cardiomyopathy, defined as an ejection fraction less than 40%. Exclusion criteria include known allergy to contrast medium, previous anaphylaxis, and renal insufficiency (serum creatinine greater than 1.5). We would like to enroll 30 patients. After giving informed consent, all eligible patients will undergo CT angiography, performed using new multi-slice technology. The results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed. Following CT angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy. Results of the CT angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease, compared to coronary angiography as the gold standard.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
VACT Healthcare System-Yale School of Medicine | |
West HAven, Connecticut, United States, 06516 |
Principal Investigator: | Aseem Vashist, M.D. | VACHS and Yale University School of Medicine |
Principal Investigator: | Mehran Sadeghi, M.D. | VACHS and Yale University School of Medicine |
Study ID Numbers: | AS0006, 00795 |
Study First Received: | January 5, 2006 |
Last Updated: | January 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00273819 History of Changes |
Health Authority: | United States: Federal Government |
Congestive heart failure, LV dysfunction |
Arterial Occlusive Diseases Coronary Disease Heart Failure Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Cardiomyopathies Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Failure Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |