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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Multidetector Computed Tomography - 64 detectors

• Registration Number: NCT00738218
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2007-02
• Status Verified: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Last Update Submitted: 2008-08-19
• Study First Posted: 2008-08-20
• Last Update Posted: 2008-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDCT	Multidetector Computed Tomography - 64 detectors	Single Arm study. All patients underwent MDCT.

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.	30 Days

Secondary Outcome Measures

Name	Time	Method
Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.	30 Days