Accrual

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.

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.

All subjects