Diagnostic Accuracy of Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors

Study Overview
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Brief Summary
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To compare the diagnostic ability of 64-detector MDCT coronary angiography with conventional invasive coronary angiography in patients with suspected coronary artery disease.

Detailed Description
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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.

Official Title
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Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors: CORE-64 Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Multidetector Computed Tomography - 64 detectors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, age 40 years or greater. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT. Suspected coronary artery disease (i.e. symptoms, signs) with a clinical indication for coronary angiography; and planned coronary angiography within the next 30 days. Able to understand and willing to sign informed consent. Exclusion Criteria: Known allergy to iodinated contrast media History of contrast-induced nephropathy History of multiple myeloma or previous organ transplantation Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula Atrial fibrillation or uncontrolled tachyarrhythmia, or heart block Evidence of severe symptomatic heart failure; moderate or severe aortic stenosis Previous coronary artery bypass or other cardiac surgery Coronary artery intervention within the last 6 months Intolerance or contraindication to beta-blockers Body Mass Index > 40.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MDCT<br>Single Arm study. All patients underwent MDCT. | Other: Multidetector Computed Tomography - 64 detectors<br>* Multidetector computed tomography angiography<br>* Other names: Aquillion 64 detector CT scanner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy to detect significant coronary artery disease in an individual patient. |  | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel. |  | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Computed Tomography, Angiography