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

August 19, 2008 updated by: Johns Hopkins University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

405

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: MDCT
Single Arm study. All patients underwent MDCT.
Other: Multidetector Computed Tomography - 64 detectors
Multidetector computed tomography angiography
Other Names:
  • Aquillion 64 detector CT scanner

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

February 1, 2007

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (ESTIMATE)

August 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2008

Last Update Submitted That Met QC Criteria

August 19, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHUCORE64
  • NA_00003755
  • NTR535

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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