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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Montefiore Medical Center
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jeffrey Levsky, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01384448
First received: June 15, 2011
Last updated: December 18, 2013
Last verified: December 2013

June 15, 2011
December 18, 2013
August 2011
August 2014   (final data collection date for primary outcome measure)
Hospital admission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01384448 on ClinicalTrials.gov Archive Site
  • Emergency Department length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Estimated cost of initial care [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Repeat visits to the Emergency Department [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • Non-fatal myocardial infarction [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Chest Pain
  • Angina
  • Angina Pectoris
  • Coronary Artery Disease
  • 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
  • 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
  • Experimental: Initial Stress Echocardiography
    Intervention: Procedure: Stress Echocardiography
  • Experimental: Initial Coronary CT Angiography
    Intervention: Procedure: Coronary CT Angiography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact: Jeffrey M Levsky, MD, PhD 718-920-4872 jlevsky@montefiore.org
United States
 
NCT01384448
MMC-11-03-107, 11SDG7380006
Yes
Jeffrey Levsky, Montefiore Medical Center
Montefiore Medical Center
American Heart Association
Principal Investigator: Jeffrey M Levsky, MD, PhD Montefiore Medical Center / Albert Einstein College of Medicine
Montefiore Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP