Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography (Core320)

August 31, 2018 updated by: Johns Hopkins University

Multi Center Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Computed Tomography

The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥ 50% and a corresponding myocardium perfusion defect in a patient with suspected coronary artery disease compared with conventional coronary angiography and single photon emission computed tomography myocardium perfusion imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Combined Coronary angiography and myocardial perfusion imaging using 320 detectors computed tomography (CORE-320) was designed as a prospective, multi-center, international, blinded study designed to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in patients with suspected coronary artery disease. The primary analysis will be a comparison of the diagnostic capability of the combination of quantitative 320-MDCT angiography and quantitative perfusion imaging to the combination of conventional coronary angiography and SPECT myocardial perfusion imaging at the patient level. A positive patient will be defined as having at least one vessel with a ≥ 50% diameter stenosis defined by quantitative coronary angiography and a corresponding positive SPECT territorial myocardial perfusion defect.

Study Type

Interventional

Enrollment (Actual)

444

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Albert Einstein Hospital
      • Sao Paulo, Brazil
        • INCOR Heart Institute University-Sao Paulo
  • Canada
      • Toronto, Canada
        • Toronto General Hospital
  • Denmark
      • Blegdamsvej, Denmark, 9, 2100
        • Rigshospitalet - University of Copenhagen
  • Germany
      • Berlin, Germany
        • Charité Humboldt University
  • Japan
      • Morioka, Japan
        • Iwate Medical University
      • TSU, Japan
        • Mie University
      • Tokyo, Japan
        • Keio University
      • Tokyo, Japan
        • St. Luke's International Hospital
  • Netherlands
      • Leiden, Netherlands
        • Leiden University
  • Singapore
      • Singapore, Singapore
        • National Heart Center
      • Singapore, Singapore
        • Mount Elizabeth Hospital
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Medicine
      • Bethesda, Maryland, United States, 20892
        • National Heart Lung and Blood Institute (NHLBI)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women Hospital

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

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients, age 45-85. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
  • Suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography; and planned coronary angiography within the next 60 days.
  • Able to understand and willing to sign the Informed Consent Form.

Exclusion Criteria:

  • Known allergy to iodinated contrast media.
  • History of contrast-induced nephropathy.
  • History of multiple myeloma or previous organ transplantation.
  • Elevated serum creatinine (> 1.5 mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula.
  • Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block).
  • Evidence of severe symptomatic heart failure (NYHA Class III or IV); Known or suspected moderate or severe aortic stenosis.
  • Previous coronary artery bypass or other cardiac surgery.
  • Coronary artery intervention within the last 6 months.

  • Known or suspected intolerance or contraindication to beta-blockers including:

    • Known allergy to beta-blockers
    • History of moderate to severe bronchospastic lung disease (including moderate to severe asthma).
  • Severe pulmonary disease (chronic obstructive pulmonary disease).
  • Presence of any other history or condition that the investigator feels would be problematic.
  • SPECT preformed in non-validated center within 60 days prior to screening.
  • SPECT performed within the previous 6 months of screening but > 60 days.
  • SPECT studies performed within 60 days of screening that include rest and stress studies performed using 2 day protocols.
  • BMI greater than 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Combined CT Angiography and Myocardial Perfusion
Single Arm study. All patients underwent combined CT Angiography and Myocardial Perfusion.
Procedure: 320 Volume Detector Computed Tomography
Single Arm Study. All patients undergo Volume (Multidetector) CT.
Other: Other: Multidetector Computed Tomography - 320 detectors
Multidetector computed tomography angiography
Other Names:
  • Aquilion ONE CT scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors in a patient with suspected coronary artery disease.
Time Frame: 30-60 Days
Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in a patient with suspected coronary artery disease.
30-60 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of volume computed tomography using 320 detectors in a vessel of a patient with suspected coronary artery disease.
Time Frame: 30-60 Days
Diagnostic accuracy of volume computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding territorial myocardium perfusion defects in a vessel of a patient with suspected coronary artery disease.
30-60 Days
Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA
Time Frame: 30-60 Days
Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA
30-60 Days
Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography.
Time Frame: 30-60 Days
Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography.
30-60 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

  • Study Chair: Joao AC Lima, MD MBA, Johns Hopkins School of Medicine

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 (Actual)

December 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00022661
  • Core320 (Other Identifier: Other)

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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