ProspEctive First Evaluation in Chest Pain Trial

NCT ID: NCT01604655

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chest Pain Shortness of Breath Suspected Acute Coronary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Coronary CT Angiography

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

Group Type ACTIVE_COMPARATOR

Coronary CT Angiography

Intervention Type PROCEDURE

CCTA

Stress Test

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

Group Type ACTIVE_COMPARATOR

Stress Test

Intervention Type PROCEDURE

Stress Test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coronary CT Angiography

CCTA

Intervention Type PROCEDURE

Stress Test

Stress Test

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seth Uretsky, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's and Roosevelt Hospital Centers

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Luke's and Roosevelt Hospitals

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27048306 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-307

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biomarkers in Acute Cardiac Care
NCT02355457 RECRUITING
MRI Evaluation of Chest Pain
NCT00001961 COMPLETED PHASE2
Low Risk Acute Coronary Syndrome
NCT01703156 COMPLETED NA