One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care (OUT-POC)

University of Oslo

Status: Enrolling

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

Treatments: Diagnostic Test: QuidelOrthos TriageTrue hs-cTnI whole-blood assay

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06853626

SDAM_FOR555568

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,500 participants in 1 patient group

TriageTrue hs-cTnI 0/1-hour algorithm

Other group

Description:

Study participants will have a venous blood sample done for hs-cTnI testing using the QuidelOrthos TriageTrue whole-blood POC assay. The treating physician will evaluate the results using an assay-specific 0/1-hour algorithm (developed by Boeddinghaus et al., 2020).

Treatment:

Diagnostic Test: QuidelOrthos TriageTrue hs-cTnI whole-blood assay