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Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.

Unstable Angina Clinical Trial

Official title:
Diagnosis and Treatment of Acute Coronary Syndrome in the Emergency Department- The Impact of Rapid Bedside cTnl on Outcome.

Clinical Trial Summary

The primary outcome in this study will be time to discharge for low-risk patients and therapeutic turnaround time for patients with NSTEMI or unstable angina.

Clinical Trial Description

Phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. Assess the reduction in time taken to dispostion or discharge patients. Assess the ability of POC testing to satisfy guidelines for a 30 minute turn around time of results. Assess and differences in clinical decision-making for other diagnostic procedures including nuclear imaging, echo, and stress treadmill, disposition from the ED, time to catherterization lab, PCI, and CafBG based on the cardiac troponinn results from the bedside analyzer and the central lab instrument.Assess the difference for in-hospital and 30 day post hospital discharge cardiac events including all-cause and cardiac-specific deaths, CHF, cardiomyopathy, and atrial and ventricular arrhythmia, beween the bedside analyzer and the central lab instrument. Assess the differences in hospital care costs for the hospitalization period, and assess direct medical and indirect productivity costs in the 30 day post hospital discharge period to patients who are diagnosed, using the bedside cTnl test and the central lab cTn tests, and subsequently treated as per the guidelines. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00276432
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 4
Start date November 2005
Completion date August 2007
View Details
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