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
  Purpose

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.


Condition Intervention
Chest Pain
Angina
Angina Pectoris
Coronary Artery Disease
Procedure: Stress Echocardiography
Procedure: Coronary CT Angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Trial Comparing Coronary CT Angiography and Stress Echocardiography for Evaluation of Low-to-Intermediate Risk Emergency Department Chest Pain Patients

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Hospital admission [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: August 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • stress echo
  • treadmill stress echocardiography
  • treadmill stress echo
  • exercise stress echocardiography
  • exercise stress echo
  • dobutamine stress echocardiography
  • dobutamine stress echo
  • ESE
  • TSE
  • DSE
  • SE
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:
  • 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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384448

Contacts
Contact: Jeffrey M Levsky, MD, PhD 718-920-4872 jlevsky@montefiore.org

Locations
United States, New York
Montefiore Medical Center - Weiler / Einstein Division Recruiting
Bronx, New York, United States, 10462
Sponsors and Collaborators
Montefiore Medical Center
American Heart Association
Investigators
Principal Investigator: Jeffrey M Levsky, MD, PhD Montefiore Medical Center / Albert Einstein College of Medicine
  More Information

No publications provided by Montefiore Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Levsky, Associate Director of Research, Department of Radiology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01384448     History of Changes
Other Study ID Numbers: MMC-11-03-107, 11SDG7380006
Study First Received: June 15, 2011
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
stress echocardiography
coronary ct angiography

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Signs and Symptoms
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on October 16, 2014