CClinicalTrials.gg
CompletedNCT01384448Updated Oct 11, 2018

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

An interventional study of Stress Echocardiography and Coronary CT Angiography in Chest Pain, Angina and Angina Pectoris, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.

Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chest Pain
  • Angina
  • Angina Pectoris
  • Coronary Artery Disease

Keywords

  • stress echocardiography
  • coronary ct angiography
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 400 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Initial Stress Echocardiography

    Procedure: Stress Echocardiography

  • Experimental
    Initial Coronary CT Angiography

    Procedure: Coronary CT Angiography

Interventions

  • ProcedureStress 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.

    Also known as: stress echo, treadmill stress echocardiography, treadmill stress echo, exercise stress echocardiography, exercise stress echo, dobutamine stress echocardiography, dobutamine stress echo, ESE, TSE, DSE, SE

  • ProcedureCoronary 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.

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. Hospital admission

    Time frame: 30 days

Secondary outcomes

  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

07

Study locations

1 site
  • Montefiore Medical Center - Weiler / Einstein Division
    Bronx, New York 10462, United States
08

References and documents

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. PubMed 24372760 ↗
  • 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. PubMed 29909113 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01384448
Lead sponsor
Montefiore Medical Center
Collaborators
American Heart Association
Responsible party
Jeffrey Levsky (Associate Director of Research, Department of Radiology, Montefiore Medical Center) — Principal investigator
First posted
Jun 29, 2011
Start date
Aug 2011
Primary completion
Feb 2016
Completion
Feb 2017
Last update
Oct 11, 2018

Study contacts

Jeffrey M Levsky, MD, PhD
principal investigator · Montefiore Medical Center/Albert Einstein College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion