ProspEctive First Evaluation in Chest Pain Trial

Not Applicable

Completed

• Conditions: Shortness of Breath; Chest Pain; Suspected Acute Coronary Syndrome
• Interventions: Procedure: Coronary CT Angiography; Procedure: Stress Test

• Registration Number: NCT01604655
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-24
• Primary Completion: 2013-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronary CT Angiography	Coronary CT Angiography	Patient admitted with chest pain is randomized to CCTA for assessment.
Stress Test	Stress Test	Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment.

Primary Outcome Measures

Name	Time	Method
Change in medical regimen	Initial hospitalization
Downstream cardiovascular testing and hospitalization	2 years
Time to discharge	Initial hospitalization

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	7 days, 30 days, 6, 12, and 24 months.	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.
Non-fatal myocardial infarction	7 days, 30 days, 6, 12, and 24 months.	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.
All-cause mortality	7 days, 30 days, 6, 12, and 24 months.	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.

Trial Locations

Locations (1)

St. Luke's and Roosevelt Hospitals; 🇺🇸 New York, New York, United States