Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain

This study is currently recruiting participants.

Verified September 2011 by Montefiore Medical Center

Sponsor:

Collaborator:

American Heart Association

Information provided by (Responsible Party):

Jeffrey Levsky, Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT01384448

First received: June 15, 2011

Last updated: September 23, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 15, 2011

Last Updated Date

September 23, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hospital admission [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01384448 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Emergency Department length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Hospital length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Estimated cost of initial care [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Repeat visits to the Emergency Department [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
Death [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
Non-fatal myocardial infarction [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain

Official Title ^ICMJE

A Randomized Trial Comparing Coronary CT Angiography and Stress Echocardiography for Evaluation of Low-to-Intermediate Risk Emergency Department Chest Pain Patients

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Chest Pain
Angina
Angina Pectoris
Coronary Artery Disease

Intervention ^ICMJE

Procedure: Stress Echocardiography
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.
Other Names:
- stress echo
- treadmill stress echocardiography
- treadmill stress echo
- exercise stress echocardiography
- exercise stress echo
- dobutamine stress echocardiography
- dobutamine stress echo
- ESE
- TSE
- DSE
- SE
Procedure: Coronary CT Angiography
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.
Other Names:
- 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

Study Arm (s)

Experimental: Initial Stress Echocardiography
Intervention: Procedure: Stress Echocardiography
Experimental: Initial Coronary CT Angiography
Intervention: Procedure: Coronary CT Angiography

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

June 2015

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jeffrey M Levsky, MD, PhD

718-920-4872

jlevsky@montefiore.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01384448

Other Study ID Numbers ^ICMJE

MMC-11-03-107, 11SDG7380006

Has Data Monitoring Committee

Yes

Responsible Party

Jeffrey Levsky, Montefiore Medical Center

Study Sponsor ^ICMJE

Montefiore Medical Center

Collaborators ^ICMJE

American Heart Association

Investigators ^ICMJE

Principal Investigator:

Jeffrey M Levsky, MD, PhD

Montefiore Medical Center / Albert Einstein College of Medicine

Information Provided By

Montefiore Medical Center

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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