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.
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
Enrollment
1,750
Oslo Accident and Emergency Outpatient Clinic
Oslo, Norway
Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
Time frame: 7-10 hours
Number of patients without significant changes (rule-out) according to the 1-hour algorithm
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
Time frame: 7-10 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
The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study
Time frame: 1 week
90 days follow-up of all recruited patients
How many will have an acute MI the next 3 months?
Time frame: 90 days
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