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

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ClinicalTrials.gov Identifier: NCT01384448
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jeffrey Levsky, Montefiore Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chest Pain Angina Angina Pectoris Coronary Artery Disease Procedure: Stress Echocardiography Procedure: Coronary CT Angiography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2011
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Hospital admission [ Time Frame: 30 days ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384448


Locations
United States, New York
Montefiore Medical Center - Weiler / Einstein Division
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
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Publications:

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 ( Other Grant/Funding Number: American Heart Association National Center )
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Emergencies
Angina Pectoris
Chest Pain
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Dobutamine
Cardiotonic Agents
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