One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
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* Procedure: 1-hour hs-cTnT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 hour-troponin<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 7-10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 1 week | 
| 90 days follow-up of all recruited patients | How many will have an acute MI the next 3 months? | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute MI, Acute myocardial infarction cardiac troponin, High-sensitivity cardiac troponin T, 0/1-hour algorithm, Outpatient clinic, Cardiac troponin, Chest pain