Clinical Trials Directory

Trials / Completed

CompletedNCT00276432

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
350 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEiSTAT point of care analyzer

Timeline

Start date
2005-11-01
Primary completion
2007-08-01
Completion
2007-08-01
First posted
2006-01-13
Last updated
2010-01-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00276432. Inclusion in this directory is not an endorsement.