ProspEctive First Evaluation in Chest Pain Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.

Detailed Description
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Currently, physicians can either choose a stress test or a CT scan of the heart to evaluate patients admitted with with chest pain. Very little is known about which test provides the best information to physicians, positively impacts patients medical care, and decreases future hospital admissions and testing. To study this the investigators are randomizing patients admitted to our hospital with chest pain to a stress test or coronary CT angiography. The investigators will then follow these patients for a 2 year period.

Official Title
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ProspEctive Randomized First Evaluation in Chest Pain Trial

Conditions
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Chest Pain, Shortness of Breath, Suspected Acute Coronary Syndrome

Intervention / Treatment
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* Procedure: Coronary CT Angiography
* Procedure: Stress Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chest pain or SOB admitted for rule out acute coronary syndrome Age ≥45 years EKG non-diagnostic for acute coronary syndrome At least 1 set of negative troponin I Exclusion Criteria: Patient with ST elevation myocardial infarction. Patients with non-ST elevation myocardial infarction. Patients with known CAD. Patients with serum creatinine > 1.5. Atrial fibrillation or marked irregular heart rhythm. Patients in whom heart rate cannot be controlled. Patient with allergies to iodinated contrast agents. Pregnant women Patients unable to give informed consent

Ages Eligible for Study
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Minimum Age: 45 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: Coronary CT Angiography<br>Patient admitted with chest pain is randomized to CCTA for assessment. | Procedure: Coronary CT Angiography<br>* CCTA<br>|
| Active Comparator: Stress Test<br>Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment. | Procedure: Stress Test<br>* Stress Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge |  | Initial hospitalization | 
| Change in medical regimen |  | Initial hospitalization | 
| Downstream cardiovascular testing and hospitalization |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain. | 7 days, 30 days, 6, 12, and 24 months. | 
| Cardiovascular mortality | This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain. | 7 days, 30 days, 6, 12, and 24 months. | 
| Non-fatal myocardial infarction | This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain. | 7 days, 30 days, 6, 12, and 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest pain, shortness of breath, suspected acute coronary syndrome, stress testing, coronary computed tomography angiography