NCT00486447

Perfusion Imaging and CT -Understanding Relative Efficacy

A Prospective Multi-center Study Comparing Cardiac Computed Tomography (CT) Using a 64-detector Row Volumetric Computed Tomography (VCT) Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.

Detailed description

This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD. Each subject will undergo the following procedures: * A Myocardial Perfusion Study (MPS) procedure, as standard of care; * An IV contrast-enhanced cardiac CT (CCTA) procedure; * A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure. When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	64 Channel VCT	cardiac CT angiography exam

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-04-01
• Completion: 2009-12-01
• First posted: 2007-06-14
• Last updated: 2017-08-23
• Results posted: 2017-08-23

Locations

1 site across 1 country: United States