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Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes

NCT00222352 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2018-02-05

No results posted yet for this study

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.

Conditions

  • Angina, Unstable

Interventions

DIAGNOSTIC_TEST

Point of Care cTnL testing

The study design will be a phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. The experimental group of interest will be patients receiving the POC cTnI test, and the control group will be patients receiving the central laboratory cTnI test. The treating physician will be blinded to the randomization and will receive only the POC results from half the study patients and only the laboratory results for the remaining half.

Sponsors & Collaborators

Principal Investigators

  • Walter B Gibler, MD · University of Cincinnati

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-11-30
Completion
2007-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00222352 on ClinicalTrials.gov