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

Coronary Artery Disease Clinical Trial

— CORE-64  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738218
• Other study ID #: JHUCORE64
• Secondary ID: NA_00003755NTR53
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: August 19, 2008
• Start date: October 2005

Study information

• Verified date: August 2008
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Multidetector Computed Tomography - 64 detectors
Multidetector computed tomography angiography

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Toshiba America Medical Systems, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.		30 Days	No
Secondary	Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.		30 Days	No