Improving the Management of Acute Coronary Syndromes in the Emergency Department (RACE)

April 3, 2013 updated by: Robert Birkhahn, MD, Integrated Medical Research LLC

Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway

By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. In addition, the investigators hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by increasing the patient to health care provider ratio.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

705

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chief complaint of chest pain
  • 35 years old or greater

Exclusion Criteria:

  • ST elevation MI
  • New Left Bundle Branch Block
  • Admission regardless of test result
  • Leaving ED against medical advice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Core Laboratory
Patients receiving serial routinely available cardiac biomarker testing in a core laboratory setting using Troponin T. (Roche Centaur)
Active Comparator: Point of Care
Patients will receive the Point of Care testing intervention using serial cardiac biomarker testing at the bedside including myoglobin, Troponin I and CK-MB. (Triage Cardiac Panel, Alere)
Device: Point of Care testing

The investigators will implement 6 months of randomized testing periods, 2 weeks each. During this 2 week block, cardiac biomarkers will be tested at the bedside in the ED using the Triage Cardiac Panel that will test for CK-MB, Myoglobin, and Troponin I.

Each blood sample that is take for point of care testing will be saved. The plasma from the saved sample will be frozen and the sample will be sent to an off-site testing center for high sensitivity troponin testing.

All patients will be followed at the 30-day mark and those patients who are discharged home from the ED will be followed within 48 hours as well.

Other Names:
  • Triage Cardiac Panel by Alere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED length of stay
Time Frame: Average of 3 hours stay in the Emergency Department
From patient check-in time to patient admit or discharge time
Average of 3 hours stay in the Emergency Department

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate of admitted patients
Time Frame: During hospital admission and at 30 days
Average hospital stay 3 days.
During hospital admission and at 30 days
Hospital Admission Rate
Time Frame: Baseline
Observing the rate at which physicians admit patients to the hospital.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrated Medical Research LLC

Collaborators

New York State Department of Health
Alere San Diego

Investigators

  • Principal Investigator: Bethany A Byrd, D.O., New York Presbyterian Brooklyn Methodist Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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