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
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Condition or disease | Intervention/treatment | Phase |
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Acute Coronary Syndrome | Device: Point of Care testing | Phase 4 |
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 |
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)
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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)
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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
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- 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
- Mortality rate of admitted patients [ Time Frame: During hospital admission and at 30 days ]Average hospital stay 3 days.
- Hospital Admission Rate [ Time Frame: Baseline ]Observing the rate at which physicians admit patients to the hospital.

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Ages Eligible for Study: | 35 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, New York | |
New York Methodist Hospital | |
Brooklyn, New York, United States, 11215 |
Principal Investigator: | Bethany A Byrd, D.O. | New York Methodist Hospital |
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 |