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

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2013 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: December 18, 2013

Last verified: December 2013

History of Changes

Purpose

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.

Condition	Intervention
Chest Pain Angina Angina Pectoris Coronary Artery Disease	Procedure: Stress Echocardiography Procedure: Coronary CT Angiography


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	A Randomized Trial Comparing Coronary CT Angiography and Stress Echocardiography for Evaluation of Low-to-Intermediate Risk Emergency Department Chest Pain Patients

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Chest Pain

Drug Information available for: Dobutamine Dobutamine hydrochloride

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	400
Study Start Date:	August 2011
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Initial Stress Echocardiography	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
Experimental: Initial Coronary CT Angiography	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

Arms

Assigned Interventions

Experimental: Initial Stress Echocardiography

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

Experimental: Initial Coronary CT Angiography

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

Eligibility


Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384448

Contacts


Contact: Jeffrey M Levsky, MD, PhD	718-920-4872	jlevsky@montefiore.org

Locations


United States, New York
Montefiore Medical Center - Weiler / Einstein Division	Recruiting
Bronx, New York, United States, 10462

Sponsors and Collaborators

Montefiore Medical Center

American Heart Association

Investigators


Principal Investigator:	Jeffrey M Levsky, MD, PhD	Montefiore Medical Center / Albert Einstein College of Medicine

More Information

No publications provided by Montefiore Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Jeffrey Levsky, Associate Director of Research, Department of Radiology, Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT01384448 History of Changes
Other Study ID Numbers:	MMC-11-03-107, 11SDG7380006
Study First Received:	June 15, 2011
Last Updated:	December 18, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:


stress echocardiography coronary ct angiography

Additional relevant MeSH terms:


Chest Pain Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pain Signs and Symptoms Vascular Diseases Dobutamine Adrenergic Agents Adrenergic Agonists	Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Autonomic Agents Cardiotonic Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Sympathomimetics Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

To Top