Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02983123
Acronym
OUT-ACS
Enrollment
1750
Registered
2016-12-06
Start date
2016-11-15
Completion date
2018-10-22
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Angina, Unstable, Non-ST Elevation Myocardial Infarction, 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

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.

Interventions

PROCEDURE1-hour hs-cTnT

Sponsors

University of Oslo
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients without significant changes (rule-out) according to the 1-hour algorithm7-10 hoursThe troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm7-10 hoursThe troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.

Secondary

MeasureTime frameDescription
Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm10 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 OAEOC1 weekThe final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study
90 days follow-up of all recruited patients90 daysHow many will have an acute MI the next 3 months?

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026