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

This study has been completed.
Sponsor:
Collaborators:
Alere San Diego
New York State Department of Health
Information provided by (Responsible Party):
Robert Birkhahn, MD, Integrated Medical Research LLC
ClinicalTrials.gov Identifier:
NCT01563250
First received: June 9, 2011
Last updated: April 3, 2013
Last verified: April 2013
History of Changes

June 9, 2011
April 3, 2013
June 2011
December 2011   (final data collection date for primary outcome measure)
ED length of stay [ Time Frame: Average of 3 hours stay in the Emergency Department ] [ Designated as safety issue: No ]
From patient check-in time to patient admit or discharge time
Same as current
Complete list of historical versions of study NCT01563250 on ClinicalTrials.gov Archive Site
  • Mortality rate of admitted patients [ Time Frame: During hospital admission and at 30 days ] [ Designated as safety issue: Yes ]
    Average hospital stay 3 days.
  • Hospital Admission Rate [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Observing the rate at which physicians admit patients to the hospital.
Same as current
Not Provided
Not Provided
 
Improving the Management of Acute Coronary Syndromes in the Emergency Department
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Acute Coronary Syndrome
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
  • 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)
    Intervention: Device: Point of Care testing
Birkhahn RH, Haines E, Wen W, Reddy L, Briggs WM, Datillo PA. Estimating the clinical impact of bringing a multimarker cardiac panel to the bedside in the ED. Am J Emerg Med. 2011 Mar;29(3):304-8. Epub 2010 Apr 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
705
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01563250
IMR-001
No
Robert Birkhahn, MD, Integrated Medical Research LLC
Integrated Medical Research LLC
  • Alere San Diego
  • New York State Department of Health
Principal Investigator: Bethany A Byrd, D.O. New York Methodist Hospital
Integrated Medical Research LLC
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP