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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Point of Care testing
Sponsored by
Integrated Medical Research LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Cardiac Biomarkers, point of care testing

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Core Laboratory

Point of Care

Arm Description

Patients receiving serial routinely available cardiac biomarker testing in a core laboratory setting using Troponin T. (Roche Centaur)

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)

Outcomes

Primary Outcome Measures

ED length of stay
From patient check-in time to patient admit or discharge time

Secondary Outcome Measures

Mortality rate of admitted patients
Average hospital stay 3 days.
Hospital Admission Rate
Observing the rate at which physicians admit patients to the hospital.

Full Information

First Posted
June 9, 2011
Last Updated
April 3, 2013
Sponsor
Integrated Medical Research LLC
Collaborators
Alere San Diego, New York State Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT01563250
Brief Title
Improving the Management of Acute Coronary Syndromes in the Emergency Department
Acronym
RACE
Official Title
Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Integrated Medical Research LLC
Collaborators
Alere San Diego, New York State Department of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, Cardiac Biomarkers, point of care testing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
705 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core Laboratory
Arm Type
No Intervention
Arm Description
Patients receiving serial routinely available cardiac biomarker testing in a core laboratory setting using Troponin T. (Roche Centaur)
Arm Title
Point of Care
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Point of Care testing
Other Intervention Name(s)
Triage Cardiac Panel by Alere
Intervention Description
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.
Primary Outcome Measure Information:
Title
ED length of stay
Description
From patient check-in time to patient admit or discharge time
Time Frame
Average of 3 hours stay in the Emergency Department
Secondary Outcome Measure Information:
Title
Mortality rate of admitted patients
Description
Average hospital stay 3 days.
Time Frame
During hospital admission and at 30 days
Title
Hospital Admission Rate
Description
Observing the rate at which physicians admit patients to the hospital.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany A Byrd, D.O.
Organizational Affiliation
New York Presbyterian Brooklyn Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20825823
Citation
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. doi: 10.1016/j.ajem.2009.12.007. Epub 2010 Apr 2.
Results Reference
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Improving the Management of Acute Coronary Syndromes in the Emergency Department

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