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Sponsors and Collaborators: |
Johns Hopkins University Toshiba |
Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00738218 |
To compare the diagnostic ability of 64-detector MDCT coronary angiography with conventional invasive coronary angiography in patients with suspected coronary artery disease.
Condition | Intervention |
Coronary Artery Disease |
Other: Multidetector Computed Tomography - 64 detectors |
MedlinePlus related topics: | CT Scans Coronary Artery Disease |
Study Type: | Interventional |
Study Design: | Diagnostic, Single Blind (Investigator), Uncontrolled, Single Group Assignment |
Official Title: | Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors: "CORE-64" Study |
Enrollment: | 405 |
Study Start Date: | October 2005 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
MDCT
Single Arm study. All patients underwent MDCT.
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Other: Multidetector Computed Tomography - 64 detectors
Multidetector computed tomography angiography
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The "Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors" or "CorE-64" study was designed to evaluate the diagnostic accuracy of multislice spiral CT angiography using 64 detector rows for identifying coronary artery stenosis in patients with suspected or known coronary artery disease. The study was designed as a prospective, multi-center, international, blinded study examining the diagnostic accuracy of 64-slice CT in comparison with CCA. The primary hypothesis of the study is that 64-slice CT coronary angiography will be able to detect significant coronary artery disease in a patient with acceptable diagnostic accuracy as compared to CCA. Significant CAD is defined as ≥ 50% stenosis as determined by quantitative analysis of CCA (QCA). The diagnostic parameters is per-patient sensitivity and specificity compared with CCA, with both point estimates and continuous measurements of diagnostic accuracy. Eligible patients will first undergo MDCT (calcium scanning and MDCTA)prior to clinically indicated conventional coronary angiography. Patients with CAC 600 or less will be included in the primary analysis. Patients will be followed for clinical events including revascularization.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Johns Hopkins University |
Toshiba |
Principal Investigator: | Joao AC Lima, M.D. | Johns Hopkins University |
Principal Investigator: | Julie M Miller, M.D. | Johns Hopkins University |
Study Chair: | Joao AC Lima, M.D. | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Joao A. C. Lima ) |
Study ID Numbers: | JHUCORE64, NA_00003755, NTR535 |
First Received: | August 19, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00738218 |
Health Authority: | United States: Institutional Review Board |
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