Trials / Completed
CompletedNCT02983123
One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,750 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate if the 1-hour rule-in/rule-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 4/6-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-in/rule-out of acute MI. All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI.
Conditions
- Non-ST Elevation Myocardial Infarction
- Acute Coronary Syndrome
- Angina, Unstable
- NSTEMI - Non-ST Segment Elevation MI
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 1-hour hs-cTnT |
Timeline
- Start date
- 2016-11-15
- Primary completion
- 2018-10-22
- Completion
- 2018-10-22
- First posted
- 2016-12-06
- Last updated
- 2019-03-14
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT02983123. Inclusion in this directory is not an endorsement.