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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oslo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care

Troponin testing requested by the treating physician

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • QuidelOrthos TriageTrue hs-cTnI whole-blood assay

    Diagnostic test

    Already described

Treatment groups

2,500 Participants
are divided into 1 treatment group
Group A: TriageTrue hs-cTnI 0/1-hour algorithmOther 1 intervention

Trial outcomes

Primary outcomes

1

Total number of acute myocardial infarctions at the index episode

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

Time frame
From baseline to 30 days
2

PROM: Health-related quality of life

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).

Time frame
At baseline and repeated after 90 days

Secondary outcomes

1

Efficiency

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

Time frame
Baseline
2

Total number of hospital referrals at index

Proportion of patients being directly hospitalised at index

Time frame
Baseline
3

Total length of stay

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

Time frame
Baseline to 24 hours
4

Composite of acute MI and all-cause death

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

Time frame
From baseline to 1 year

Other outcomes

1

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

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).

Time frame
From baseline to 1 year

Sponsors and contacts

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University of Oslo

Lead sponsor

Norwegian Health Association

Collaborator

Oslo University Hospital

Collaborator

QuidelOrtho

Collaborator

Vestre Viken Hospital Trust

Collaborator

The Dam Foundation

Collaborator

Amsterdam UMC

Collaborator

Sorlandet Hospital HF

Collaborator