Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)

Study Overview
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Brief Summary
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Three main clinical outcomes will be assessed: Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study; Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction; Cost-effectiveness To this end, SPARC is organized with two distinct specific objectives with important differences in patient population and endpoints. Specific Aim 1: To evaluate the impact of stress perfusion imaging with SPECT or PET, CT Angiography, and hybrid PET-CT on post-test resource utilization. The primary endpoint of specific aim 1 is to compare the impact of combined myocardial perfusion-coronary anatomy data to that of perfusion only [stress SPECT, stress cardiac PET (without CTA)] and anatomy only (CTA alone) on post-test resource utilization, as measured by referral to cardiac catheterization within 90 days of index noninvasive testing, in patients without CAD. Secondary endpoints: to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and hybrid PET-CT, stress SPECT, and CTA, as defined by coronary angiography; to compare the referral rate to revascularization within 90 days of cardiac catheterization. Specific Aim 2: To compare the incremental prognostic value and risk stratification of stress perfusion imaging with SPECT or PET, CT coronary angiography, and combined perfusion-anatomy imaging approaches. The primary endpoint of specific aim 2 is to compare the incremental value of stress perfusion only (stress PET and stress SPECT), coronary anatomy only (CTA data), and combined perfusion-anatomy studies (PET+CTA and SPECT+CTA) over clinical, historical and stress test data for the prediction of cardiac death and nonfatal myocardial infarction. Secondary endpoints: to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late (>6 month from index study) referral to revascularization, or late (>6 month from index study) hospitalization for chest pain or heart failure; to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of all cause mortality. In addition, the ability of these modalities -together and separately- to risk stratify patients is a primary goal of specific aim 2.

Official Title
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SPARC, Including Its Pilot CT Angiographic Study, is a Prospective, Open-label, Multicenter, Sequentially Sampled, Observational Registry to Define the Clinical Value of Stress Perfusion (Stress SPECT, Stress PET), Noninvasive Angiography (CTA) and Combined Perfusion-anatomy (PET/CT) Studies in Patients With Known or Suspected CAD With Respect to Post-test Resource Utilization and Prediction of Cardiac Death and Non-fatal Myocardial Infarction

Conditions
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Known CAD, or Intermediate-high Pretest Likelihood for CAD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred for a clinical stress SPECT, stress PET, CTA or PET-CT study Intermediate to high pretest likelihood for CAD (>.25;as defined by ACC/AHA Stable Angina Guidelines) without prior MI/PCI/CABG. These are considered diagnostic patients. or Documented known CAD as defined by prior MI/PCI/CABG Provide signed informed consent to participate in the study Exclusion Criteria: Low pretest likelihood for CAD (<=.25; as defined by ACC/AHA Stable Angina Guidelines). Major concomitant noncardiac disease or social condition/situation that in the opinion of the investigator will preclude the patient from participation in the study follow-up. Concurrent or prior(within last 30 days) participation in other research studies using investigational drugs or devices. Presence of a permanent automated internal cardiac defibrillator (AICD) Known non-ischemic cardiomyopathy Chest pain at rest within 48 hours prior to the index noninvasive imaging test

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CORONARY ANATOMY, Coronary Artery Disease, SPECT, PET, PET/CT, CTA