Ignite Creation Date:
2024-05-06 @ 9:26 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02983123
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2016-11-29
Brief Title:
One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Introduction of an 1-hour Algorithm for High-sensitivity Cardiac-specific Troponin T for Faster Assessment of NSTEMI in a Low-prevalence Population at Oslo Accident and Emergency Outpatient Clinic
Status:
COMPLETED
Status Verified Date:
2019-03
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:
OUT-ACS
Brief Summary:
This study aims to evaluate if the 1-hour rule-inrule-out algorithm for a high-sensitivity cardiac troponin T hs-cTnT is safe and effective for use in the primary care where the patients have a lower pretest probability of an acute myocardial infarction MI During this study troponins will be collected at 0- 1- and 46-hours where absolute changes in the values will decide whether the patient need hospitalization or not
Detailed Description:
Many patients seek Oslo Accident and Emergency Outpatient Clinic OAEOC with chest pain The majority of these patients have symptoms suggestive of a benign non-cardiac chest pain These patients do not need a directly transfer to the hospital but can be admitted to the Observation Unit at the OAEOC for further pre-hospital testing including serial troponins for a safe rule-out of acute MI The main goal of this study is to improve the current routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for a faster rule-inrule-out of acute MI
All recruited patients will have serial troponins drawn at 0 1- and 46 hours with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 46 hours The cut-off levels used within the 01-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI
All recruited patients will have serial troponins drawn at 0 1- and 46 hours with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 46 hours The cut-off levels used within the 01-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 201613308 | OTHER | PVO OUS | None |