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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Chest Pain; Angina; Angina Pectoris; Coronary Artery Disease	Procedure: Stress Echocardiography; Procedure: Coronary CT Angiography	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	August 2011
Actual Primary Completion Date :	February 2016
Actual Study Completion Date :	February 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Hospital admission [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. Emergency Department length of stay [ Time Frame: 30 days ]
2. Hospital length of stay [ Time Frame: 30 days ]
3. Estimated cost of initial care [ Time Frame: 30 days ]
4. Repeat visits to the Emergency Department [ Time Frame: 30 days and 1 year ]
5. Death [ Time Frame: 30 days and 1 year ]
6. Non-fatal myocardial infarction [ Time Frame: 30 days and 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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 ( Other Grant/Funding Number: American Heart Association National Center )
First Posted:	June 29, 2011
Last Update Posted:	March 22, 2017
Last Verified:	March 2017

Keywords provided by Jeffrey Levsky, Montefiore Medical Center:

stress echocardiography; coronary ct angiography

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Emergencies; Angina Pectoris; Chest Pain; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pain; Neurologic Manifestations	Nervous System Diseases; Signs and Symptoms; Dobutamine; Cardiotonic Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Adrenergic beta-1 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents