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

This study has been completed.
Sponsor:
Collaborator:
Toshiba America Medical Systems, Inc.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00738218
First received: August 19, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors: "CORE-64" Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Diagnostic Accuracy to detect significant coronary artery disease in an individual patient. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

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.
 Other: Multidetector Computed Tomography - 64 detectors
Multidetector computed tomography angiography
Other Name: Aquillion 64 detector CT scanner

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738218

Sponsors and Collaborators
Johns Hopkins University
Toshiba America Medical Systems, Inc.
Investigators
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
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joao A. C. Lima, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00738218     History of Changes
Other Study ID Numbers: JHUCORE64, NA_00003755, NTR535
Study First Received: August 19, 2008
Last Updated: August 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Coronary Artery Disease
Computed Tomography
Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013