Clinical trial NCT01384448: Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Angina
Angina Pectoris
Coronary Artery Disease
Keywords: stress echocardiography
coronary ct angiography
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2011-06-29
Enrollment: 400
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Hospital admission
timeFrame: 30 days
Secondary outcomes:
measure: Emergency Department length of stay
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Estimated cost of initial care
timeFrame: 30 days
measure: Repeat visits to the Emergency Department
timeFrame: 30 days and 1 year
measure: Death
timeFrame: 30 days and 1 year
measure: Non-fatal myocardial infarction
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center - Weiler / Einstein Division
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Jeffrey M Levsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.