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

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 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

Further study details as provided by Robert Birkhahn, MD, Integrated Medical Research LLC:

Primary Outcome Measures:

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:

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.


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

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 (Adult, Senior)
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

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:

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.


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

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

ClinicalTrials.gov processed this record on September 21, 2017

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