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ProspEctive First Evaluation in Chest Pain Trial (PERFECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01604655
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Tracking Information
First Submitted Date  ICMJE May 17, 2012
First Posted Date  ICMJE May 24, 2012
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2014)
  • Time to discharge [ Time Frame: Initial hospitalization ]
  • Change in medical regimen [ Time Frame: Initial hospitalization ]
  • Downstream cardiovascular testing and hospitalization [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • Change in medication regimen. [ Time Frame: 7 days, 30 days, 6, 12, and 24 months. ]
    The purpose of this outcome is to measure the impact the test the patient has been randomized too has on medical management.
  • Change in CAD risk profile (blood pressure, lipid profile, weight, and HgbA1C [ Time Frame: 7 days, 30 days, 6, 12, and 24 months. ]
    The purpose of this outcome is to measure the impact the test the patient has been randomized too has on their CAD risk profile.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2014)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • Time to discharge from hospital [ Time Frame: 7 days ]
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ProspEctive First Evaluation in Chest Pain Trial
Official Title  ICMJE ProspEctive Randomized First Evaluation in Chest Pain Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Chest Pain
  • Shortness of Breath
  • Suspected Acute Coronary Syndrome
Intervention  ICMJE
  • Procedure: Coronary CT Angiography
    CCTA
  • Procedure: Stress Test
    Stress Test
Study Arms  ICMJE
  • Active Comparator: Coronary CT Angiography
    Patient admitted with chest pain is randomized to CCTA for assessment.
    Intervention: Procedure: Coronary CT Angiography
  • Active Comparator: Stress Test
    Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment.
    Intervention: Procedure: Stress Test
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)		 411
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2012)		 500
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01604655
Other Study ID Numbers  ICMJE 11-307
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party St. Luke's-Roosevelt Hospital Center
Original Responsible Party Seth Uretsky, St. Luke's-Roosevelt Hospital Center, Director, Cardiac CT and MRI
Current Study Sponsor  ICMJE St. Luke's-Roosevelt Hospital Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seth Uretsky, MD St. Luke's and Roosevelt Hospital Centers
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP