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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384448
• Other study ID #: MMC-11-03-107
• Secondary ID: 11SDG7380006
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina
• Angina Pectoris
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Emergencies
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center - Weiler / Einstein Division	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital admission		30 days
Secondary	Emergency Department length of stay		30 days
Secondary	Hospital length of stay		30 days
Secondary	Estimated cost of initial care		30 days
Secondary	Repeat visits to the Emergency Department		30 days and 1 year
Secondary	Death		30 days and 1 year
Secondary	Non-fatal myocardial infarction		30 days and 1 year