Clinical trial NCT00222352: Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes
Official title: Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina, Unstable
Keywords: Unstable Angina
Non-ST-segment Myocardial Infarction
Myocardial Necrosis
Troponin I
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Abbott
name: Jewish Hospital, Cincinnati, Ohio
name: University of Pennsylvania
name: Stanford University
name: Mayo Clinic
First posted: 2005-09-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 21 years or older, presenting with symptoms suggestive of acute coronary syndromes, and having cardiac biomarker tests ordered by the treating emergency physician were enrolled. Patients with a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation) or a 12-lead ECG diagnostic for acute myocardial infarction were excluded. Patients were enrolled at 4 sites across the United States between December 2004 and November 2006, with final data collection and verification occurring by March 2007.

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.

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 criteria: Inclusion criteria

* Age \>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

Primary outcomes:
measure: Time to disposition from the ED
timeFrame: The time from blood draw to initiation of therapy or to disposition
Secondary outcomes:
measure: Time to departure
timeFrame: time of discharge to home or to the time of transfer to an inpatient setting
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Cincinnati
country: United States
facility: The Jewish Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Cincinnati
name: Walter B Gibler, MD
role: STUDY_CHAIR
References: