ProspEctive First Evaluation in Chest Pain Trial (PERFECT)

March 7, 2016 updated by: St. Luke's-Roosevelt Hospital Center

ProspEctive Randomized First Evaluation in Chest Pain Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

411

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to discharge
Time Frame: Initial hospitalization
Initial hospitalization
Change in medical regimen
Time Frame: Initial hospitalization
Initial hospitalization
Downstream cardiovascular testing and hospitalization
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days, 30 days, 6, 12, and 24 months.
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.
7 days, 30 days, 6, 12, and 24 months.
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.
7 days, 30 days, 6, 12, and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (ESTIMATE)

May 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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