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 volunteersQualifiers
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
Single group
Treatments tested in this trial
QuidelOrthos TriageTrue hs-cTnI whole-blood assay
Diagnostic testAlready described
Treatment groups
Trial outcomes
Primary outcomes
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
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).
Secondary outcomes
Efficiency
The proportion of patients finished triaged as rule-out or rule-in by the protocol at index
Total number of hospital referrals at index
Proportion of patients being directly hospitalised at index
Total length of stay
Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge)
Composite of acute MI and all-cause death
To assess the prognostic performance of the algorithm after 30, 90, and 365 days
Other outcomes
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).
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