Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00276432
Enrollment
350
Registered
2006-01-13
Start date
2005-11-30
Completion date
2007-08-31
Last updated
2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ST-Elevation Myocardial Infarction, Unstable Angina

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.

Interventions

DEVICEiSTAT point of care analyzer

Sponsors

Abbott
CollaboratorINDUSTRY
University of Cincinnati
CollaboratorOTHER
Corewell Health East
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Time to discharge for low-risk patients
Therapeutic turnaround time for patients with NSTEMI or unstable angina

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026