Clinical trial NCT01604655: ProspEctive First Evaluation in Chest Pain Trial
Official title: ProspEctive Randomized First Evaluation in Chest Pain Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Shortness of Breath
Suspected Acute Coronary Syndrome
Keywords: Chest pain
shortness of breath
suspected acute coronary syndrome
stress testing
coronary computed tomography angiography
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 411
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to discharge
timeFrame: Initial hospitalization
measure: Change in medical regimen
timeFrame: Initial hospitalization
measure: Downstream cardiovascular testing and hospitalization
timeFrame: 2 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 7 days, 30 days, 6, 12, and 24 months.
measure: Cardiovascular mortality
timeFrame: 7 days, 30 days, 6, 12, and 24 months.
measure: Non-fatal myocardial infarction
timeFrame: 7 days, 30 days, 6, 12, and 24 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's and Roosevelt Hospitals
state: New York
Study officials:
affiliation: St. Luke's and Roosevelt Hospital Centers
name: Seth Uretsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uretsky S, Argulian E, Supariwala A, Agarwal SK, El-Hayek G, Chavez P, Awan H, Jagarlamudi A, Puppala SP, Cohen R, Rozanski A. Comparative effectiveness of coronary CT angiography vs stress cardiac imaging in patients following hospital admission for chest pain work-up: The Prospective First Evaluation in Chest Pain (PERFECT) Trial. J Nucl Cardiol. 2017 Aug;24(4):1267-1278. doi: 10.1007/s12350-015-0354-6. Epub 2016 Apr 5.