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

NCT06853626 | Recruiting DMC

• 1 other identifier: SDAM_FOR555568
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 6

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• 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

  From baseline to 30 days

• 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).

  At baseline and repeated after 90 days

Secondary Outcomes (12)

• Efficiency

  Baseline

• Total number of hospital referrals at index

  Baseline

• Total length of stay

  Baseline to 24 hours

• Composite of acute MI and all-cause death

  From baseline to 1 year

• PROM: Cardiac Anxiety

  At baseline and repeated after 90 days

Other Outcomes (1)

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

  From baseline to 1 year

Study Arms (1)

TriageTrue hs-cTnI 0/1-hour algorithm

OTHER

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).

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

Interventions

QuidelOrthos TriageTrue hs-cTnI whole-blood assay DIAGNOSTIC_TEST

Already described

TriageTrue hs-cTnI 0/1-hour algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care
• Troponin testing requested by the treating physician

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oslo: lead
• Norwegian Health Association: collaborator
• Oslo University Hospital: collaborator
• QuidelOrtho: collaborator
• Vestre Viken Hospital Trust: collaborator
• The Dam Foundation: collaborator
• Amsterdam UMC: collaborator
• Sørlandet Hospital: collaborator

Study Sites (6)

Lyngen Emergency Primary Care Centre

Lyngseidet, Lyngen, Norway

RECRUITING

Alta Emergency Primary Care Centre

Alta, Norway

RECRUITING

Drammen Emergency Primary Care Centre

Drammen, Norway

RECRUITING

Fredrikstad and Hvaler Emergency Primary Care Centre

Fredrikstad, Norway

RECRUITING

Oslo Accident and Emergency Outpatient Clinic

Oslo, Norway

RECRUITING

Trondheim Intermunicipal Emergency Primary Care Centre

Trondheim, Norway

RECRUITING

Related Publications (2)

• Johannessen TR, Vallersnes OM, Larstorp ACK, Halvorsen S, Atar D. One-Hour Troponin Using a High-Sensitivity Point-of-Care Assay in Emergency Primary Care: The OUT-POC Pilot Study. Cardiology. 2025 Mar 7:1-13. doi: 10.1159/000545127. Online ahead of print.

  PMID: 40058362 RESULT

• Johannessen TR, Vallersnes OM, Larstorp ACK, Halvorsen S, Atar D. Authors' Response Letter - Expanding the Use of Point-of-Care hs-cTnI in Emergency Primary Care: Insights from the OUT-POC Pilot Study. Cardiology. 2025 May 22:1-3. doi: 10.1159/000546344. Online ahead of print. No abstract available.

  PMID: 40418919 RESULT

Related Links

• OUT-POC pilot study
• OUT-POC pilot study; Authors' Response Letter

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Tonje R. Johannessen, MD, PhD

CONTACT

+47 95169272; t.r.johannessen@medisin.uio.no

Odd Martin Vallersnes, Professor

CONTACT

o.m.vallersnes@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 3, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (6)