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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by University Emergency Physicians.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: September 14, 2005
Last updated: February 27, 2007
Last verified: February 2007
  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 4

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

Resource links provided by NLM:


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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00222352     History of Changes
Other Study ID Numbers: TJH 0428
Study First Received: September 14, 2005
Last Updated: February 27, 2007
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

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

ClinicalTrials.gov processed this record on October 16, 2014