Study Comparing CT Scan and Stress Test in Patients With Known Coronary Artery Disease Hospitalized for Chest Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with known coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.

Official Title
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A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease

Conditions
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Coronary Artery Disease, Angina Pectoris, Unstable Angina, Acute Coronary Syndrome

Intervention / Treatment
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* Procedure: Coronary CT angiography
* Procedure: Myocardial perfusion imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient admitted for chest pain / pressure or other suggestive symptoms patient has known coronary artery disease (with or without prior revascularization) patient has clinical need for non-invasive cardiac evaluation Exclusion Criteria: evidence of ongoing myocardial infarction or hemodynamic instability ischemia on EKG (greater than 1mm ST segment deviation) contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction) heart rhythm precluding EKG gating pregnancy

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Experimental: Initial coronary CT angiography<br>EKG-gated, computed tomography angiography of the coronary arteries during heart rate control | Procedure: Coronary CT angiography<br>* EKG-gated, computed tomography angiography of the coronary arteries during heart rate control<br>* Other names: Computed tomography angiography of the coronary arteries;|
| Active Comparator: Initial nuclear stress test<br>Stress radionuclide myocardial perfusion imaging | Procedure: Myocardial perfusion imaging<br>* Stress radionuclide myocardial perfusion imaging<br>* Other names: myocardial perfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (time to discharge) |  | 1 month | 
| Number of participants that have a subsequent non-fatal myocardial infarction |  | 1 year | 
| Number of participants that die due to any cause |  | 1 year | 
| Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, controlled clinical trial, comparative effectiveness research, chest pain, angina pectoris, non-invasive cardiac imaging, nuclear stress testing, coronary CT angiography, coronary catheterization, coronary revascularization