Clinical trial NCT06853626: One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: TriageTrue
POC
hs-cTnI
0/1-hour algorithm
troponin
chest pain
primary care
OOH
out-of-hours
acute myocardial infarction
point-of-care
OUT-POC
QuidelOrtho
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian Health Association
name: Oslo University Hospital
name: QuidelOrtho
name: Vestre Viken Hospital Trust
name: The Dam Foundation
First posted: 2025-03-03
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, investigator-initiated pre-post intervention study aiming to evaluate implementation of the QuidelOrthos TriageTrue hs-cTnI whole-blood assay at six Norwegian (non-randomised) emergency primary care clinics.

A control group will be identified to estimate the effect of the OUT-POC protocol. We will benefit from registry data to 1) estimate hospital referrals before the intervention in the same regions and 2) establish an external control group consisting of municipalities that are not using POC hs-cTn testing.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Total number of acute myocardial infarctions at the index episode
timeFrame: From baseline to 30 days
measure: PROM: Health-related quality of life
timeFrame: At baseline and repeated after 90 days
Secondary outcomes:
measure: Efficiency
timeFrame: Baseline
measure: Total number of hospital referrals at index
timeFrame: Baseline
measure: Total length of stay
timeFrame: Baseline to 24 hours
measure: Composite of acute MI and all-cause death
timeFrame: From baseline to 1 year
measure: PROM: Cardiac Anxiety
timeFrame: At baseline and repeated after 90 days
measure: PROM: Depression
timeFrame: At baseline and repeated after 90 days
measure: PROM: Insomnia
timeFrame: At baseline and repeated after 90 days
measure: PROM: Burden of chest pain
timeFrame: At baseline and repeated after 90 days
measure: Incremental cost-effectiveness ratio
timeFrame: From baseline to 1 year
measure: Societal costs
timeFrame: From baseline to 1 year
measure: Healthcare utilization
timeFrame: From baseline to 1 year
measure: Healthcare costs
timeFrame: From baseline to 1 year
Other outcomes:
measure: Performance of the TriageTrue hs-cTnI whole-blood assay and clinical risk scores
timeFrame: From baseline to 1 year
Locations:
city: Lyngseidet
country: Norway
facility: Lyngen Emergency Primary Care Centre
state: Lyngen
city: Alta
country: Norway
facility: Alta Emergency Primary Care Centre
city: Drammen
country: Norway
facility: Drammen Emergency Primary Care Centre
city: Fredrikstad
country: Norway
facility: Fredrikstad and Hvaler Emergency Primary Care Centre
city: Oslo
country: Norway
facility: Oslo Accident and Emergency Outpatient Clinic
city: Trondheim
country: Norway
facility: Trondheim Intermunicipal Emergency Primary Care Centre
Study officials:
References: