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.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
444
Single Arm Study. All patients undergo Volume (Multidetector) CT.
Multidetector computed tomography angiography
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
National Heart Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women Hospital
Boston, Massachusetts, United States
Albert Einstein Hospital
São Paulo, Brazil
INCOR Heart Institute University-Sao Paulo
São Paulo, Brazil
Toronto General Hospital
Toronto, Canada
Rigshospitalet - University of Copenhagen
Blegdamsvej, Denmark
Charite Humboldt University
Berlin, Germany
Iwate Medical University
Morioka, Japan
...and 6 more locations
Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors in a patient with suspected coronary artery disease.
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.
Time frame: 30-60 Days
Diagnostic accuracy of volume computed tomography using 320 detectors in a vessel of a patient with suspected coronary artery disease.
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.
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
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 perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography.
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
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