Improving the Management of Acute Coronary Syndromes in the Emergency Department

NCT01563250 | Completed Phase 4

• 1 other identifier: IMR-001
• Study Type: interventional
• Target: 705
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Cardiac Biomarkers; point of care testing

Outcome Measures

Primary Outcomes (1)

• ED length of stay

  From patient check-in time to patient admit or discharge time

  Average of 3 hours stay in the Emergency Department

Secondary Outcomes (2)

• Mortality rate of admitted patients

  During hospital admission and at 30 days

• Hospital Admission Rate

  Baseline

Study Arms (2)

Core Laboratory

NO INTERVENTION

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

Point of Care

ACTIVE COMPARATOR

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

Interventions

Point of Care testing DEVICE

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.

Also known as: Triage Cardiac Panel by Alere

Point of Care

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chief complaint of chest pain
• years old or greater

You may not qualify if:

• ST elevation MI
• New Left Bundle Branch Block
• Admission regardless of test result
• Leaving ED against medical advice

Sponsors & Collaborators

• Integrated Medical Research LLC: lead
• Alere San Diego: collaborator
• New York State Department of Health: collaborator

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related 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.

  PMID: 20825823 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Bethany A Byrd, D.O.

  New York Presbyterian Brooklyn Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: March 26, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)