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ProspEctive First Evaluation in Chest Pain Trial (PERFECT)

Primary Purpose

Chest Pain, Shortness of Breath, Suspected Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coronary CT Angiography
Stress Test
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Chest pain, shortness of breath, suspected acute coronary syndrome, stress testing, coronary computed tomography angiography

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Luke's and Roosevelt Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Coronary CT Angiography

Stress Test

Arm Description

Patient admitted with chest pain is randomized to CCTA for assessment.

Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment.

Outcomes

Primary Outcome Measures

Time to discharge
Change in medical regimen
Downstream cardiovascular testing and hospitalization

Secondary Outcome Measures

All-cause mortality
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
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
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.

Full Information

First Posted
May 17, 2012
Last Updated
March 7, 2016
Sponsor
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01604655
Brief Title
ProspEctive First Evaluation in Chest Pain Trial
Acronym
PERFECT
Official Title
ProspEctive Randomized First Evaluation in Chest Pain Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Shortness of Breath, Suspected Acute Coronary Syndrome
Keywords
Chest pain, shortness of breath, suspected acute coronary syndrome, stress testing, coronary computed tomography angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coronary CT Angiography
Arm Type
Active Comparator
Arm Description
Patient admitted with chest pain is randomized to CCTA for assessment.
Arm Title
Stress Test
Arm Type
Active Comparator
Arm Description
Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment.
Intervention Type
Procedure
Intervention Name(s)
Coronary CT Angiography
Intervention Description
CCTA
Intervention Type
Procedure
Intervention Name(s)
Stress Test
Intervention Description
Stress Test
Primary Outcome Measure Information:
Title
Time to discharge
Time Frame
Initial hospitalization
Title
Change in medical regimen
Time Frame
Initial hospitalization
Title
Downstream cardiovascular testing and hospitalization
Time Frame
2 years
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
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.
Time Frame
7 days, 30 days, 6, 12, and 24 months.
Title
Cardiovascular mortality
Description
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.
Time Frame
7 days, 30 days, 6, 12, and 24 months.
Title
Non-fatal myocardial infarction
Description
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.
Time Frame
7 days, 30 days, 6, 12, and 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Uretsky, MD
Organizational Affiliation
St. Luke's and Roosevelt Hospital Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's and Roosevelt Hospitals
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27048306
Citation
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.
Results Reference
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ProspEctive First Evaluation in Chest Pain Trial

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