NCT01604655

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

May 17, 2012

Last Update Submit

March 7, 2016

Conditions

Keywords

Chest painshortness of breathsuspected acute coronary syndromestress testingcoronary computed tomography angiography

Outcome Measures

Primary Outcomes (3)

  • Time to discharge

    Initial hospitalization

  • Change in medical regimen

    Initial hospitalization

  • Downstream cardiovascular testing and hospitalization

    2 years

Secondary Outcomes (3)

  • All-cause mortality

    7 days, 30 days, 6, 12, and 24 months.

  • Cardiovascular mortality

    7 days, 30 days, 6, 12, and 24 months.

  • Non-fatal myocardial infarction

    7 days, 30 days, 6, 12, and 24 months.

Study Arms (2)

Coronary CT Angiography

ACTIVE COMPARATOR

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

Procedure: Coronary CT Angiography

Stress Test

ACTIVE COMPARATOR

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

Procedure: Stress Test

Interventions

CCTA

Coronary CT Angiography
Stress TestPROCEDURE

Stress Test

Stress Test

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's and Roosevelt Hospitals

New York, New York, 10025, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chest PainDyspnea

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Seth Uretsky, MD

    St. Luke's and Roosevelt Hospital Centers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2012

First Posted

May 24, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations