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

NCT ID: NCT01384448

Last Updated: 2018-10-11

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-02-28

Brief Summary

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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

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Conditions

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Chest Pain Angina Angina Pectoris Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Initial Stress Echocardiography

Group Type EXPERIMENTAL

Stress Echocardiography

Intervention Type PROCEDURE

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.

Initial Coronary CT Angiography

Group Type EXPERIMENTAL

Coronary CT Angiography

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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stress echo treadmill stress echocardiography treadmill stress echo exercise stress echocardiography exercise stress echo dobutamine stress echocardiography dobutamine stress echo ESE TSE DSE SE 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

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Levsky

Associate Director of Research, Department of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey M Levsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

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Montefiore Medical Center - Weiler / Einstein Division

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24372760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29909113 (View on PubMed)

Other Identifiers

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11SDG7380006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MMC-11-03-107

Identifier Type: -

Identifier Source: org_study_id

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