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Clinical Trials/NCT00276432
NCT00276432CompletedPhase 4

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

Mayo Clinic2 sites in 1 country350 target enrollmentStarted: November 1, 2005Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
350
Locations
2
Primary Endpoint
Time to discharge for low-risk patients

Study Overview

Brief 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.

Detailed 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Double

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient must be 21 years old or older with chest pain or other symptoms that lead to drawing cardiac biomarkers.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time to discharge for low-risk patients

Therapeutic turnaround time for patients with NSTEMI or unstable angina

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (2)

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