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RECRUITING
NCT06853626
NA

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

Sponsor: University of Oslo

View on ClinicalTrials.gov

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.

Official 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2025-06-27

Completion Date

2029-12-31

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

QuidelOrthos TriageTrue hs-cTnI whole-blood assay

Already described

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