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Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes

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ClinicalTrials.gov Identifier: NCT00222352
Recruitment Status : Unknown
Verified February 2007 by University Emergency Physicians.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : February 28, 2007
Information provided by:

Study Description
Brief Summary:
In a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. Our hypothesis: point-of-care testing for troponin I will decrease the time for disposition of patients with possible ACS in the emergency setting and decrease the time required for administering appropriate therapies for these patients.

Condition or disease Phase
Angina, Unstable Phase 4

Detailed Description:
Cardiac troponin I is routinely used in the emergency department as a risk stratification tool for detecting myocardial necrosis in patients with possible acute coronary syndrome. It is our hypothesis that having bedside, point-of-care testing for TnI in the ED will decrease time needed to disposition patients to home from the ED or send to the cardiac catheterization laboratory or intensive care setting. Similarly, having point-of-care testing in the ED should decrease the time required to deliver anti-platelet drugs such as aspirin and glycoprotein IIb/IIIa inhibitors and anti-thrombin agents such as heparin to high risk patients found to have a positive TnI test. This will be evaluated in a randomized, controlled clinical trial of 2000 patients. Half will have the test performed in the ED at the bedside (point-of-care) while the other half will receive the usual lab results obtained from the central lab (typically requiring 1.5-2 hours to return).

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes
Study Start Date : December 2004
Estimated Study Completion Date : December 2006
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age greater than or equal to 21 years old
  • Chest pain or other symptoms that lead to drawing cardiac bio-markers for possible ACS diagnosis

Exclusion Criteria:

  • Presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
  • Presentation with ECG diagnostic for STEMI
Contacts and Locations

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): NCT00222352

United States, California
Stanford University
Stanford, California, United States, 94305-6203
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Ohio
The Jewish Hospital
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6205
Sponsors and Collaborators
University Emergency Physicians
Abbott Point of Care
Jewish Hospital, Cincinnati, Ohio
University of Pennsylvania
Stanford University
Mayo Clinic
Study Chair: Walter B Gibler, MD EMCREG International; University Emergency Physicians, Inc; University of Cincinnati College of Medicine
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00222352     History of Changes
Other Study ID Numbers: TJH 0428
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 28, 2007
Last Verified: February 2007

Keywords provided by University Emergency Physicians:
Unstable Angina
Non-ST-segment Myocardial Infarction
Myocardial Necrosis
Troponin I

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms