Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

Study Overview
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Brief Summary
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The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.

Official Title
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Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Myocardial perfusion imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of coronary artery disease New or worsening symptoms Out-patients and in-hospital patients Exclusion Criteria: Creatinine above 2.5 mg% PCI within prior 6 months Pregnant females Cardiomyopathy (LVEF below 40%) Significant valvular heart disease Body mass index greater than 38

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SPECT myocardial perfusion imaging<br> | Procedure: Myocardial perfusion imaging<br>* Randomization assignment to one of SPECT or PET myocardial perfusion imaging<br>|
| Active Comparator: PET myocardial perfusion imaging<br> | Procedure: Myocardial perfusion imaging<br>* Randomization assignment to one of SPECT or PET myocardial perfusion imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic failure of SPECT vs PET |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of diagnostic or clinical failure |  | 12 months | 
| Each of individual components of clinical failure |  | 12 months | 
| Relative effect on quality of life |  | 3 months, 6 months | 
| Relative direct and downstream costs |  | 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography