One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome
- Conditions
- NSTEMI - Non-ST Segment Elevation MIAcute Coronary SyndromeNon-ST Elevation Myocardial InfarctionAngina, Unstable
- Interventions
- Procedure: 1-hour hs-cTnT
- Registration Number
- NCT02983123
- Lead Sponsor
- Oslo University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1750
- Patients at the outpatient clinic with suspected non-cardiac chest pain/symptoms who need further testing for a safe rule-out of an acute MI
- Written informed consent
- Acute STEMI (ST-elevation myocardial infarction) (directly to the hospital)
- Strong suspicion of an acute NSTEMI/unstable angina (directly to the hospital)
- Terminal kidney disease with a glomerular filtration rate (GFR) < 30
- Unable to communicate in Norwegian, Swedish, Danish or English language
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 hour-troponin 1-hour hs-cTnT 1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours.
- Primary Outcome Measures
Name Time Method Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm 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 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.
- Secondary Outcome Measures
Name Time Method 90 days follow-up of all recruited patients 90 days How many will have an acute MI the next 3 months?
Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC 1 week The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study
Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm 10 hours Significant changes between the first and second ECG? 6 hours
Trial Locations
- Locations (1)
Oslo Accident and Emergency Outpatient Clinic
🇳🇴Oslo, Norway