Overview

This trial is active, not recruiting.

Condition angina, unstable
Phase phase 4
Sponsor University Emergency Physicians
Collaborator Abbott Point-of-Care
Start date December 2004
End date December 2006
Trial size 2000 participants
Trial identifier NCT00222352, TJH 0428

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model natural history
Time perspective longitudinal

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by University Emergency Physicians.