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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Chest Pain; Angina Pectoris; Angina
• Intervention / Treatment: Procedure: Stress Echocardiography; Procedure: Coronary CT Angiography

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: SE; DSE; stress echo; treadmill stress echocardiography; treadmill stress echo; exercise stress echocardiography; exercise stress echo; dobutamine stress echocardiography; dobutamine stress echo; ESE; TSE
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: CCT; Cardiac CT; CTA; CCTA; Coronary CTA; Coronary CT; Cardiac CTA; Coronary Artery CT; Coronary Artery CTA; CT Angiography of the Coronary Arteries; Computed Tomography Angiography of the Coronary Arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital admission	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital length of stay	30 days
Emergency Department 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
Non-fatal myocardial infarction	30 days and 1 year

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Jeffrey M Levsky, MD, PhD, Montefiore Medical Center/Albert Einstein College of Medicine

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 29, 2011

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: stress echocardiography; coronary ct angiography
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Disease Attributes; Coronary Disease; Coronary Artery Disease; Emergencies; Chest Pain; Angina Pectoris; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: MMC-11-03-107; 11SDG7380006 (Other Grant/Funding Number: American Heart Association National Center)