NCT00934037

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Arterial Occlusive Diseases
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Vascular Diseases
• Arteriosclerosis
• Ischemia
• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2017-09-01
• First posted: 2009-07-08
• Last updated: 2018-09-05

Locations

16 sites across 8 countries: United States, Brazil, Canada, Denmark, Germany, Japan, Netherlands, Singapore