Perfusion Imaging and CT -Understanding Relative Efficacy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: 64 Channel VCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging<br>General imaging subjects receiving CT exams | Device: 64 Channel VCT<br>* cardiac CT angiography exam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth. | Number of subjects with CT for detection purposes | through study completion, an expected average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 1 year outcomes after initial MPS exam |