Clinical trial NCT02983123: One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-ST Elevation Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
NSTEMI - Non-ST Segment Elevation MI
Keywords: Acute MI
Acute myocardial infarction cardiac troponin
High-sensitivity cardiac troponin T
0/1-hour algorithm
Outpatient clinic
Cardiac troponin
Chest pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2016-12-06
Enrollment: 1750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Oslo Accident and Emergency Outpatient Clinic with symptoms suggestive of a benign non-cardiac chest pain, who needs further pre-hospital testing at the Observation Unit for a safe rule-out of an acute MI.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm
timeFrame: 7-10 hours
measure: Number of patients without significant changes (rule-out) according to the 1-hour algorithm
timeFrame: 7-10 hours
Secondary outcomes:
measure: Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm
timeFrame: 10 hours
measure: Significant changes between the first and second ECG?
timeFrame: 6 hours
measure: Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC
timeFrame: 1 week
measure: 90 days follow-up of all recruited patients
timeFrame: 90 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Accident and Emergency Outpatient Clinic
Study officials:
affiliation: Oslo University Hospital and University of Oslo, Norway
name: Dan Atar, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Johannessen TR, Halvorsen S, Atar D, Vallersnes OM. Performance of the Novel Observation Group Criteria of the European Society of Cardiology (ESC) 0/1-Hour Algorithm in a Low-Risk Population. J Am Heart Assoc. 2022 Apr 5;11(7):e024927. doi: 10.1161/JAHA.121.024927. Epub 2022 Mar 30. No abstract available.
citation: Johannessen TR, Atar D, Vallersnes OM, Larstorp ACK, Mdala I, Halvorsen S. Comparison of a single high-sensitivity cardiac troponin T measurement with the HEART score for rapid rule-out of acute myocardial infarction in a primary care emergency setting: a cohort study. BMJ Open. 2021 Feb 24;11(2):e046024. doi: 10.1136/bmjopen-2020-046024.
citation: Johannessen TR, Vallersnes OM, Halvorsen S, Larstorp ACK, Mdala I, Atar D. Pre-hospital One-Hour Troponin in a Low-Prevalence Population of Acute Coronary Syndrome: OUT-ACS study. Open Heart. 2020 Jul;7(2):e001296. doi: 10.1136/openhrt-2020-001296.