One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome (OUT-ACS)

University of Oslo (UIO)

Status: Completed

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

Treatments: Procedure: 1-hour hs-cTnT

Study type: Observational

Funder types: Other

Identifiers

NCT02983123

2016/1241/REK

2016/13308 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,750 participants in 1 patient group

1 hour-troponin

Description:

1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours.

Treatment:

Procedure: 1-hour hs-cTnT