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

Not Applicable

Not yet recruiting

• Conditions: Acute Myocardial Infarction (AMI); Chest Pain; Acute Coronary Syndromes (ACS); Non-cardiac Chest Pain; Troponin; Point of Care Testing; Out-of-hours Medical Care; Primary Care

• Registration Number: NCT06853626
• Lead Sponsor: University of Oslo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Start: 2025-05-02
• Primary Completion: 2026-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total number of acute myocardial infarctions at the index episode	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
PROM: Health-related quality of life	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 Outcome Measures

Name	Time	Method
Efficiency	Baseline	The proportion of patients finished triaged as rule-out or rule-in by the protocol at index
Total number of hospital referrals at index	Baseline	Proportion of patients being directly hospitalised at index
Total length of stay	Baseline to 24 hours	Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge)
PROM: Depression	At baseline and repeated after 90 days	Changes in depression, measured by the Patient Health Questionnaire-4 (PHQ-4)
Incremental cost-effectiveness ratio	From baseline to 1 year	Difference in quality-adjusted life-years by using the OUT-POC protocol compared to standard care (control)
Healthcare costs	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.
Composite of acute MI and all-cause death	From baseline to 1 year	To assess the prognostic performance of the algorithm after 30, 90, and 365 days
PROM: Burden of chest pain	At baseline and repeated after 90 days	Changes in chest pain frequency, avoidance, intensity and duration, measured by Jonsbu's questionnaire
Societal costs	From baseline to 1 year	Proportion of production loss/sick leave due to chest pain-related diagnoses
PROM: Cardiac Anxiety	At baseline and repeated after 90 days	Changes in cardiac-related anxiety, measured by the Cardiac Anxiety Questionnaire (CAQ)
PROM: Insomnia	At baseline and repeated after 90 days	Changes in sleep disturbances, measured by the Sleep Condition Indicator-02
Healthcare utilization	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

Trial Locations

Locations (6)

Lyngen Emergency Primary Care Centre; 🇳🇴 Lyngseidet, Lyngen, Norway

Alta Emergency Primary Care Centre; 🇳🇴 Alta, Norway

Drammen Emergency Primary Care Centre; 🇳🇴 Drammen, Norway

Fredrikstad and Hvaler Emergency Primary Care Centre; 🇳🇴 Fredrikstad, Norway

Oslo Accident and Emergency Outpatient Clinic; 🇳🇴 Oslo, Norway

Trondheim Intermunicipal Emergency Primary Care Centre; 🇳🇴 Trondheim, Norway