Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02620397
Status:
UNKNOWN
Last Update Posted:
2015-12-15
First Post:
2015-11-27
Brief Title:
Clinical Study to Validate the Use of a New Point of Care Troponin I Test
Sponsor:
Trinity Biotech
Organization:
Trinity Biotech
Study Overview
Official Title:
Clinical Study to Validate the Use of a New Point of Care Troponin I Test as an Aid in the Diagnosis of Myocardial Infarction and Prognosis of Subjects Presenting With Symptoms of Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 trial is designed as a prospective multi-center observational study of all-comers eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome ACS
Detailed Description:
This trial is designed as a prospective multi-center observational study of all-comers eligible adult subjects presenting to participating Emergency Departments EDs with symptoms suggestive of ACS andor myocardial ischemia Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel
After obtaining written informed consent subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care POC Analyzer Blood draws and testing will occur at 4 intervals over 24 hours
After obtaining written informed consent subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care POC Analyzer Blood draws and testing will occur at 4 intervals over 24 hours
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