One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome (OUT-ACS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02983123|
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment|
|Non-ST Elevation Myocardial Infarction Acute Coronary Syndrome Angina, Unstable NSTEMI - Non-ST Segment Elevation MI||Procedure: 1-hour hs-cTnT|
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.
|Study Type :||Observational|
|Actual Enrollment :||1750 participants|
|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|
|Actual Study Start Date :||November 15, 2016|
|Actual Primary Completion Date :||October 22, 2018|
|Actual Study Completion Date :||October 22, 2018|
1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours.
Procedure: 1-hour hs-cTnT
- Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm [ Time Frame: 7-10 hours ]The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
- Number of patients without significant changes (rule-out) according to the 1-hour algorithm [ Time Frame: 7-10 hours ]The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
- Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm [ Time Frame: 10 hours ]
- Significant changes between the first and second ECG? [ Time Frame: 6 hours ]
- Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC [ Time Frame: 1 week ]The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study
- 90 days follow-up of all recruited patients [ Time Frame: 90 days ]How many will have an acute MI the next 3 months?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983123
|Oslo Accident and Emergency Outpatient Clinic|
|Oslo, Norway, 0182|
|Study Director:||Dan Atar, MD, PhD||Oslo University Hospital and University of Oslo, Norway|