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

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ClinicalTrials.gov Identifier: NCT01563250
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : April 4, 2013
Sponsor:
Collaborators:
Alere San Diego
New York State Department of Health
Information provided by (Responsible Party):
Robert Birkhahn, MD, Integrated Medical Research LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: Point of Care testing Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 705 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway
Study Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011
Arms and Interventions
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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 Name: Triage Cardiac Panel by Alere


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality rate of admitted patients [ Time Frame: During hospital admission and at 30 days ]
    Average hospital stay 3 days.

  2. Hospital Admission Rate [ Time Frame: Baseline ]
    Observing the rate at which physicians admit patients to the hospital.


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563250


Locations
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
Integrated Medical Research LLC
Alere San Diego
New York State Department of Health
Investigators
Principal Investigator: Bethany A Byrd, D.O. New York Methodist Hospital
More Information
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Publications:

Responsible Party: Robert Birkhahn, MD, Director, Integrated Medical Research LLC
ClinicalTrials.gov Identifier: NCT01563250     History of Changes
Other Study ID Numbers: IMR-001
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Robert Birkhahn, MD, Integrated Medical Research LLC:
Acute Coronary Syndrome
Cardiac Biomarkers
point of care testing

Additional relevant MeSH terms:
Syndrome
Emergencies
Acute Coronary Syndrome
Disease
Pathologic Processes
 Disease Attributes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases