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

Johns Hopkins University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Other: Multidetector Computed Tomography - 64 detectors

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00738218

NA_00003755

JHUCORE64

NTR535

Details and patient eligibility

About

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

Full 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.

Enrollment

405 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.