ProspEctive First Evaluation in Chest Pain Trial (PERFECT)

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2014 by St. Luke's-Roosevelt Hospital Center

Sponsor:

Information provided by (Responsible Party):

St. Luke's-Roosevelt Hospital Center

ClinicalTrials.gov Identifier:

NCT01604655

First received: May 17, 2012

Last updated: December 26, 2014

Last verified: October 2014

History of Changes

Purpose

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

Condition	Intervention
Chest Pain Shortness of Breath Suspected Acute Coronary Syndrome	Procedure: Coronary CT Angiography Procedure: Stress Test


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	ProspEctive Randomized First Evaluation in Chest Pain Trial

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Chest Pain

U.S. FDA Resources

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:

Time to discharge [ Time Frame: Initial hospitalization ] [ Designated as safety issue: No ]
Change in medical regimen [ Time Frame: Initial hospitalization ] [ Designated as safety issue: No ]
Downstream cardiovascular testing and hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All-cause mortality [ Time Frame: 7 days, 30 days, 6, 12, and 24 months. ] [ Designated as safety issue: Yes ]
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.
Cardiovascular mortality [ Time Frame: 7 days, 30 days, 6, 12, and 24 months. ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 7 days, 30 days, 6, 12, and 24 months. ] [ Designated as safety issue: Yes ]
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.


Estimated Enrollment:	500
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2015
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604655

Contacts


Contact: Seth Uretsky, MD	212-523-2159	suretsky@chpnet.org

Locations


United States, New York
St. Luke's and Roosevelt Hospitals	Recruiting
New York, New York, United States, 10025
Contact: Seth Uretsky, MD 212-523-2159 suretsky@chpnet.org
Principal Investigator: Seth Uretsky, MD

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators


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

More Information

No publications provided


Responsible Party:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT01604655 History of Changes
Other Study ID Numbers:	11-307
Study First Received:	May 17, 2012
Last Updated:	December 26, 2014
Health Authority:	United States: Institutional Review Board

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:


Chest Pain Acute Coronary Syndrome Dyspnea Syndrome Angina Pectoris Cardiovascular Diseases Disease Heart Diseases	Myocardial Ischemia Pain Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

ClinicalTrials.gov processed this record on February 26, 2015

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