ProspEctive First Evaluation in Chest Pain Trial (PERFECT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 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: October 20, 2014
Last verified: May 2012
  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:


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

Primary Outcome Measures:
  • Change in medication regimen. [ Time Frame: 7 days, 30 days, 6, 12, and 24 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The purpose of this outcome is to measure the impact the test the patient has been randomized too has on their CAD risk profile.


Secondary Outcome Measures:
  • Time to discharge from hospital [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • 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: October 20, 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:
Acute Coronary Syndrome
Chest Pain
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 October 21, 2014