Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206817
Status:
WITHDRAWN
Last Update Posted:
2015-07-21
First Post:
2005-09-13
Brief Title:
Rapid Assessment of Cardiac Markers for the Evaluation of Acute Coronary Syndrome RACE-ACS
Sponsor:
Abbott RDx Cardiometabolic
Organization:
Abbott RDx Cardiometabolic
Study Overview
Official Title:
Rapid Assessment of Cardiac Markers for the Evaluation of Acute Coronary Syndrome RACE-ACS
Status:
WITHDRAWN
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 neededED 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 testingIn 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 formatThe patients and their medical records will be followed for a period of thirty days and sixmonths after enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None