Perfusion Imaging and CT -Understanding Relative Efficacy (PICTURE)

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.

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.

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.

Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.

Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).

Inclusion Criteria: Patients with an intermediate probability risk for coronary artery disease. Subject has symptoms of suspected ischemic heart disease. Subject is at intermediate risk for coronary artery disease Exclusion Criteria: The subject has undergone a prior CCTA within 6 months prior to entering the study. The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure The subject has hemodynamic or active clinical instability: Acute chest pain (sudden onset); Cardiac shock; Unstable blood pressure (BP); Severe congestive heart failure or acute pulmonary edema.