Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06853626

One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care

Acute chest pain is a prevalent medical emergency in primary emergency care settings. Triage of chest pain prior to hospital admission presents significant challenges due to the absence of sufficiently sensitive diagnostic tools. Clinical signs, symptoms, risk assessment scores, or a normal electrocardiogram (ECG) can reliably exclude acute myocardial infarction (MI). This diagnostic uncertainty has resulted in chest pain being the second most common cause for acute hospital referrals from Norwegian emergency primary care, even though chest pain is frequently non-cardiac in origin.

In acute MI events, cardiac troponins are released into the bloodstream from the damaged myocardium, where low values are used to exclude MI. Until recently, such testing has necessitated using high-sensitivity cardiac troponin (hs-cTn) assays, which have been limited to hospital laboratories. However, recent technological advancements in point-of-care (POC) testing allow access to whole-blood assays that meet high-sensitivity criteria.

In this upcoming project, the investigators will evaluate the implementation of a whole-blood POC assay (QuidelOrtho TriageTrue hs-cTnI) across six Norwegian emergency primary care clinics. The study plans to enrol 2,500 patients over a period of 1.5 years. The clinical performance of the novel strategy will be investigated, as well as its impact on healthcare utilization and hospital referrals compared to standard care. Additionally, the investigators will assess the prevalence of persistent chest pain and its effects on quality of life, alongside psychological stress and anxiety, through validated questionnaires.

This project aims to offer better and more comprehensive management of the large group of emergency primary care patients with acute chest pain, contributing to reduced hospital referrals, improved quality of life, and more sustainable use of healthcare services.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyngen Emergency Primary Care Centre, Lyngseidet, Lyngen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care
  • Troponin testing requested by the treating physician

Exclusion criteria

  • Acute STEMI (direct hospital referral required)
  • Haemodynamically unstable (direct hospital referral required)
  • Not able to provide written, informed consent (i.e., due to time restraints, language barriers, impaired cognitive function, or other reasons)

Treatment and study plan

QuidelOrthos TriageTrue hs-cTnI whole-blood assay

Diagnostic Test

Already described

Primary outcomes

  1. Total number of acute myocardial infarctions at the index episode

    Time frame: From baseline to 30 days

    Proportion of acute myocardial infarction at baseline, to assess the predictive performance of the TriageTrue 0/1-hour algorithm (incl. safety and accuracy) at index

  2. PROM: Health-related quality of life

    Time frame: At baseline and repeated after 90 days

    Differences in health-related quality of life among chest pain participants will be assessed through self-reported EQ-5D questionnaire with five levels (EQ-5D-5L) incl. the EQ-5D visual analogue scale (EQ VAS).

Secondary outcomes

  1. Efficiency

    Time frame: Baseline

    The proportion of patients finished triaged as rule-out or rule-in by the protocol at index

  2. Total number of hospital referrals at index

    Time frame: Baseline

    Proportion of patients being directly hospitalised at index

  3. Total length of stay

    Time frame: Baseline to 24 hours

    Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge)

  4. Composite of acute MI and all-cause death

    Time frame: From baseline to 1 year

    To assess the prognostic performance of the algorithm after 30, 90, and 365 days

  5. PROM: Cardiac Anxiety

    Time frame: At baseline and repeated after 90 days

    Changes in cardiac-related anxiety, measured by the Cardiac Anxiety Questionnaire (CAQ)

  6. PROM: Depression

    Time frame: At baseline and repeated after 90 days

    Changes in depression, measured by the Patient Health Questionnaire-4 (PHQ-4)

  7. PROM: Insomnia

    Time frame: At baseline and repeated after 90 days

    Changes in sleep disturbances, measured by the Sleep Condition Indicator-02

  8. PROM: Burden of chest pain

    Time frame: At baseline and repeated after 90 days

    Changes in chest pain frequency, avoidance, intensity and duration, measured by Jonsbu's questionnaire

  9. Incremental cost-effectiveness ratio

    Time frame: From baseline to 1 year

    Difference in quality-adjusted life-years by using the OUT-POC protocol compared to standard care (control)

  10. Societal costs

    Time frame: From baseline to 1 year

    Proportion of production loss/sick leave due to chest pain-related diagnoses

  11. Healthcare utilization

    Time frame: From baseline to 1 year

    Total number and type of treatment and follow-up in primary and secondary care due to chest pain-related diagnoses

  12. Healthcare costs

    Time frame: From baseline to 1 year

    Total costs of assessing patients with chest pain in emergency primary care by using the protocol compared to usual care (control), including unit costs per treatment, visit, stay.

Other outcomes

  1. Performance of the TriageTrue hs-cTnI whole-blood assay and clinical risk scores

    Time frame: From baseline to 1 year

    Pre-planned subanalyses to evaluate the performance of various clinical risk scores integrating a single hs-cTnI POC measurement (incl. the History, Electrocardiogram, Age, Risk factors, and Troponin (HEART) score and the Troponin-only Manchester Acute Coronary Symdrome (T-MACS) score).

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Amsterdam UMC
  • Norwegian Health Association
  • Oslo University Hospital
  • QuidelOrtho
  • Sorlandet Hospital HF
  • The Dam Foundation
  • Vestre Viken Hospital Trust

Registry information

Official study title

Improved Management of Acute Chest Pain in Emergency Primary Care. The OUT-POC Study (One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care)

Acronym: OUT-POC

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Mar 3, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.