NCT06853626

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	QuidelOrthos TriageTrue hs-cTnI whole-blood assay	Already described

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2025-03-03
• Last updated: 2025-12-10

Locations

6 sites across 1 country: Norway