ProspEctive First Evaluation in Chest Pain Trial (PERFECT)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chest Pain; Shortness of Breath; Suspected Acute Coronary Syndrome	Procedure: Coronary CT Angiography; Procedure: Stress Test	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	411 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	ProspEctive Randomized First Evaluation in Chest Pain Trial
Study Start Date :	September 2011
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Coronary CT Angiography; Patient admitted with chest pain is randomized to CCTA for assessment.	Procedure: Coronary CT Angiography; CCTA
Active Comparator: Stress Test; Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment.	Procedure: Stress Test; Stress Test

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Time to discharge [ Time Frame: Initial hospitalization ]
2. Change in medical regimen [ Time Frame: Initial hospitalization ]
3. Downstream cardiovascular testing and hospitalization [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. All-cause mortality [ Time Frame: 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.
2. Cardiovascular mortality [ Time Frame: 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.
3. Non-fatal myocardial infarction [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
St. Luke's and Roosevelt Hospitals
New York, New York, United States, 10025

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

Principal Investigator:	Seth Uretsky, MD	St. Luke's and Roosevelt Hospital Centers

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT01604655 History of Changes
Other Study ID Numbers:	11-307
First Posted:	May 24, 2012
Last Update Posted:	March 8, 2016
Last Verified:	March 2016

Keywords provided by St. Luke's-Roosevelt Hospital Center:

Chest pain; shortness of breath; suspected acute coronary syndrome; stress testing; coronary computed tomography angiography

Additional relevant MeSH terms:

Acute Coronary Syndrome; Chest Pain; Dyspnea; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases	Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory