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ProspEctive First Evaluation in Chest Pain Trial (PERFECT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01604655
First Posted: May 24, 2012
Last Update Posted: March 8, 2016
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.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ProspEctive Randomized First Evaluation in Chest Pain Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to discharge [ Time Frame: Initial hospitalization ]
  • Change in medical regimen [ Time Frame: Initial hospitalization ]
  • Downstream cardiovascular testing and hospitalization [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • 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.


Enrollment: 411
Study Start Date: September 2011
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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604655


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

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01604655     History of Changes
Other Study ID Numbers: 11-307
First Submitted: May 17, 2012
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