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

Study Overview
=================
Brief Summary
-----------------
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 coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.

Official Title
-----------------
A Randomized Trial Comparing Multi-Detector Coronary CT Angiography and Stress Myocardial Perfusion Imaging as the Initial Test for the Diagnosis of Coronary Artery Disease in Intermediate Risk Patients Admitted for Chest Pain

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

Intervention / Treatment
-----------------
* Procedure: Coronary Computed Tomography Angiography
* Procedure: Stress Nuclear Myocardial Perfusion Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient admitted for chest pain or pressure patient at intermediate short term risk of MI or death (AHA/ACC guidelines) Exclusion Criteria: prior diagnosis of coronary artery disease evidence of ongoing myocardial infarction (and other high risk criteria per AHA/ACC guidelines) contraindications to EKG-gated CT scanning with iodinated intravenous contrast under beta-blockade pregnancy presence of an implanted pacemaker or defibrillator stress myocardial perfusion imaging, coronary CTA or coronary catheterization within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTA<br>Initial EKG-gated computed tomography angiography of the coronary arteries | Procedure: Coronary Computed Tomography Angiography<br>* 64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary)<br>* Other names: CTA of the Coronary Arteries;|
| Active Comparator: MPI<br>Initial nuclear stress myocardial perfusion imaging | Procedure: Stress Nuclear Myocardial Perfusion Imaging<br>* Usually dual-isotope perfusion imaging at rest (201-Thallium) and at stress (99m-Technetium-MIBI). Some patients will have a 2-day MIBI protocol. Gated SPECT and attenuation-correction images will be obtained. Treadmill stress will be performed. If a patient is unable to exercise, adenosine or dobutamine will be given.<br>* Other names: nuclear cardiology;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary catheterization that does not lead to re-vascularization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay (time to discharge) |  | usually from hours to a few days (average about one day) | 
| Non-fatal myocardial infarction |  | 1 year | 
| Death (all cause) |  | 1 year | 
| Post-test renal dysfunction |  | usually within a few days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress myocardial perfusion imaging, coronary computed tomography angiography