Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain
This study is ongoing, but not recruiting participants.
Sponsor:
Montefiore Medical Center
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: March 14, 2016
Last verified: March 2016
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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 ]
| Enrollment: | 400 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | February 2017 |
| Primary Completion Date: | February 2016 (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:
|
| 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:
|
Eligibility| Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Publications:
| 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: | March 14, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 30, 2016