Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222352
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2005-09-14
Brief Title:
Diagnosis and Treatment of ACS in the ED The Impact of Rapid Bedside cTnI Testing on Outcomes
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department The Impact of Rapid Bedside cTnI Testing on Outcomes
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dispo-ACS
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 IIbIIIa 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 15-2 hours to return
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None