Rapid Assessment of Cardiac Markers for the Evaluation of Acute Coronary Syndrome (RACE-ACS)
Status: | Withdrawn |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2003 |
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.
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.
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.
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.
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.
We found this trial at
6
sites
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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