Rapid Assessment of Cardiac Markers for the Evaluation of Acute Coronary Syndrome (RACE-ACS)

This study has been terminated.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00206817
First received: September 13, 2005
Last updated: April 26, 2006
Last verified: April 2006
  Purpose

This clinical trial is being conducted to 1) evaluate the possible usefulness of a panel of cardiac markers in assessing emergency department patients with possible acute coronary syndrome, 2) evaluate the usefulness of BNP in assessing emergency department patients with possible acute coronary syndrome, 3) determine if BNP can be used to predict adverse events during hospitalization and in the emergency department, and 4) evaluate how a Point-of-Care testing platform affects resource utilization in the emergency department.


Condition Intervention Phase
Acute Coronary Syndrome
Device: Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Rapid Assessment of Cardiac Markers for the Evaluation of Acute Coronary Syndrome (RACE-ACS)

Further study details as provided by Biosite:

Primary Outcome Measures:
  • Sensitivity and specificity of the three-marker versus the four-marker panelDetermine the added benefit of BNP in the diagnosis of patients with ACS

Secondary Outcome Measures:
  • Determine the economic and resource utilization benefit of the POC platform vs. standard lab testing

Estimated Enrollment: 1000
Study Start Date: October 2003
Detailed Description:

The correct diagnosis of acute coronary syndrome (ACS) remains a frequent significant challenge for emergency physicians. Over eight million chest pain patients present annually and despite promising advances in diagnosis, over four percent of ACS patients are mistakenly discharged home. While the history and physical, cardiac risk factor assessment, ECG, and cardiac marker determination are all included in the assessment and risk stratification of patients presenting with possible ACS, this assessment is clearly far from perfect. Improved rapid and accurate means of assessment in this population in the ED are clearly needed.ED patients with chest discomfort will be screened and approached for study enrollment. Consenting patients meeting the study inclusion and exclusion criteria will be enrolled. Point-of-care serial cardiac marker measurements will be performed. Based on a web-based computerized randomization system, half (50%) the patients willundergo routine central laboratory testing only. Half (50%) of the patients will undergopoint-of-care markers performed in the ED in addition to routine central laboratory testing.In this second group, central laboratory test results will be blinded from the ED physicianuntil the disposition time. BNP will be blinded and not reported to physicians for the first 500 patients (Phase I). After the first 500 patients have been enrolled, an interim analysis will be performed to determine the clinical utility of BNP in patient assessment. After physician education of these results, the trial will resume for the remaining 500 patients (Phase II). In Phase II, BNP levels will be provided to the physicians using the same time and randomization format.The patients and their medical records will be followed for a period of thirty days and sixmonths after enrollment.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age greater than or equal to 21 years at the time of enrollment Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician obtaining an ECG and cardiac markers for the patient’s evaluation New onset or worsening symptoms within six hours of presentation to the ED.

Exclusion Criteria:

History of CHF per patient history or in the available medical record. History of end stage renal disease on dialysis. Refused informed consent.4) Refused medical record review and telephone follow up at 30 days and six months.

  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: NCT00206817

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Wake Forest Univ. Baptist Med. Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0769
Cleveland Clinic Foundation Dept. of Emergency Medicine
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: Andra L Blomkalns, MD University of Cinncinati
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206817     History of Changes
Other Study ID Numbers: 020
Study First Received: September 13, 2005
Last Updated: April 26, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014