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
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Device: Point of Care testing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway

Further study details as provided by Integrated Medical Research LLC:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 705
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: Robert Birkhahn, MD, Director, Integrated Medical Research LLC
ClinicalTrials.gov Identifier: NCT01563250     History of Changes
Other Study ID Numbers: IMR-001
Study First Received: June 9, 2011
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Emergencies
Acute Coronary Syndrome
Disease Attributes
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014