NCT01384448

Brief Summary

The purpose of this study is to determine whether stress echocardiography or computed tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to select appropriate candidates for hospitalization and further work-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

June 15, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

March 1, 2017

Enrollment Period

4.5 years

First QC Date

June 15, 2011

Last Update Submit

October 9, 2018

Conditions

Chest PainAnginaAngina PectorisCoronary Artery Disease

Keywords

stress echocardiographycoronary ct angiography

Outcome Measures

Primary Outcomes (1)

  • Hospital admission

    30 days

Secondary Outcomes (6)

  • Emergency Department length of stay

    30 days

  • Hospital length of stay

    30 days

  • Estimated cost of initial care

    30 days

  • Repeat visits to the Emergency Department

    30 days and 1 year

  • Death

    30 days and 1 year

  • +1 more secondary outcomes

Study Arms (2)

Initial Stress Echocardiography

EXPERIMENTAL
Procedure: Stress Echocardiography

Initial Coronary CT Angiography

EXPERIMENTAL
Procedure: Coronary CT Angiography

Interventions

Stress EchocardiographyPROCEDURE

Stress echocardiography will be performed once. Treadmill stress is default. Patients that cannot exercise will receive dobutamine stress with or without atropine. Definity intravenous contrast will be given when needed.

Also known as: stress echo, treadmill stress echocardiography, treadmill stress echo, exercise stress echocardiography, exercise stress echo, dobutamine stress echocardiography, dobutamine stress echo, ESE, TSE, DSE, SE
Initial Stress Echocardiography
Coronary CT AngiographyPROCEDURE

64-detector, resting EKG-gated coronary CT angiography will be performed once. Patients with elevated heart rates will be given oral and/or intravenous metoprolol. Prospective gating with reduced tube current will be default. Retrospective gating with tube current modulation will be used in patients with higher heart rates.

Also known as: Cardiac CT, Cardiac CTA, Coronary CT, Coronary CTA, Coronary Artery CT, Coronary Artery CTA, CT Angiography of the Coronary Arteries, Computed Tomography Angiography of the Coronary Arteries, CTA, CCT, CCTA
Initial Coronary CT Angiography

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presentation to the Emergency Department with chest pain
  • Low-to-intermediate risk of coronary disease per Diamond-Forrester criteria
  • Free of known coronary artery disease

You may not qualify if:

  • Inability to undergo both stress echo or coronary CT for any reason
  • Contraindication to intravenous iodinated contrast
  • Dysrhythmia precluding EKG gating
  • Heart rate greater than 60 with contraindication to beta blockers
  • Administration of beta blockers within the last 12 hours
  • Known severe cardiac valvular disease or pulmonary hypertension
  • Stress echocardiography, coronary CT or catheterization within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center - Weiler / Einstein Division

The Bronx, New York, 10462, United States

Location

Related Publications (2)

  • Levsky JM, Haramati LB, Taub CC, Spevack DM, Menegus MA, Travin MI, Vega S, Lerer R, Brown-Manhertz D, Hirschhorn E, Tobin JN, Garcia MJ. Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain. Echocardiography. 2014 Jul;31(6):744-50. doi: 10.1111/echo.12464. Epub 2013 Dec 23.

    PMID: 24372760BACKGROUND

  • Levsky JM, Haramati LB, Spevack DM, Menegus MA, Chen T, Mizrachi S, Brown-Manhertz D, Selesny S, Lerer R, White DJ, Tobin JN, Taub CC, Garcia MJ. Coronary Computed Tomography Angiography Versus Stress Echocardiography in Acute Chest Pain: A Randomized Controlled Trial. JACC Cardiovasc Imaging. 2018 Sep;11(9):1288-1297. doi: 10.1016/j.jcmg.2018.03.024. Epub 2018 Jun 13.

    PMID: 29909113BACKGROUND

MeSH Terms

Conditions

Chest PainAngina PectorisCoronary Artery Disease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Jeffrey M Levsky, MD, PhD

    Montefiore Medical Center/Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Research, Department of Radiology

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 29, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2016

Study Completion

February 1, 2017

Last Updated

October 11, 2018

Record last verified: 2017-03

Locations

US(1)