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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University Emergency Physicians
Abbott Point-of-Care
Jewish Hospital, Cincinnati, Ohio
University of Pennsylvania
Stanford University
Mayo Clinic
Information provided by: University Emergency Physicians
ClinicalTrials.gov Identifier: NCT00222352
  Purpose

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 Phase
Angina, Unstable
Phase IV

MedlinePlus related topics:   Angina   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Convenience Sample, Prospective Study
Official Title:   Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes

Further study details as provided by University Emergency Physicians:

Estimated Enrollment:   2000
Study Start Date:   December 2004
Estimated Study Completion Date:   December 2006

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).

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222352

Locations
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

Investigators
Study Chair:     Walter B Gibler, MD     EMCREG International; University Emergency Physicians, Inc; University of Cincinnati College of Medicine    
  More Information


EMCREG International Website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   TJH 0428
First Received:   September 14, 2005
Last Updated:   February 27, 2007
ClinicalTrials.gov Identifier:   NCT00222352
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Ischemia
Chest Pain
Signs and Symptoms
Necrosis
Acute Coronary Syndrome
Emergencies
Infarction
Myocardial Infarction
Angina, Unstable

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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