Improving the Management of Acute Coronary Syndromes in the Emergency Department

Acute Coronary Syndrome Clinical Trial

— RACE  

Official title:

Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563250
• Other study ID #: IMR-001
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2011
• Last updated: April 3, 2013
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2013
• Source: Integrated Medical Research LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York

Sponsors (3)

Lead Sponsor	Collaborator
Integrated Medical Research LLC	Alere San Diego, New York State Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ED length of stay	From patient check-in time to patient admit or discharge time	Average of 3 hours stay in the Emergency Department	No
Secondary	Mortality rate of admitted patients	Average hospital stay 3 days.	During hospital admission and at 30 days	Yes
Secondary	Hospital Admission Rate	Observing the rate at which physicians admit patients to the hospital.	Baseline	No