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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TriageTrue hs-cTnI 0/1-hour algorithm

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).

Group Type OTHER

QuidelOrthos TriageTrue hs-cTnI whole-blood assay

Intervention Type DIAGNOSTIC_TEST

Already described

Interventions

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QuidelOrthos TriageTrue hs-cTnI whole-blood assay

Already described

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Tonje R. Johannessen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lyngen Emergency Primary Care Centre

Lyngseidet, Lyngen, Norway

Site Status RECRUITING

Alta Emergency Primary Care Centre

Alta, , Norway

Site Status RECRUITING

Drammen Emergency Primary Care Centre

Drammen, , Norway

Site Status RECRUITING

Fredrikstad and Hvaler Emergency Primary Care Centre

Fredrikstad, , Norway

Site Status RECRUITING

Oslo Accident and Emergency Outpatient Clinic

Oslo, , Norway

Site Status RECRUITING

Trondheim Intermunicipal Emergency Primary Care Centre

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Tonje R. Johannessen, MD, PhD

Role: CONTACT

[email protected]

+47 95169272

Odd Martin Vallersnes, Professor

Role: CONTACT

[email protected]

Facility Contacts

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Bent Håkan Lindberg, MD, PhD

Role: primary

Anne H. Davidsen, MD, PhD student

Role: primary

Marthe H. Prytz, MD

Role: primary

Simon Andrup, MD, PhD student

Role: primary

Tonje R. Johannessen, MD, PhD

Role: primary

[email protected]

Bjarne Austad, MD, PhD

Role: primary

References

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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.

Reference Type RESULT

PMID: 40058362 (View on PubMed)

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.

Reference Type RESULT

PMID: 40418919 (View on PubMed)

Other Identifiers

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SDAM_FOR555568

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Point-of-Care Troponin Testing in the Emergency Department

Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department

A Study of Population and Sex-specific Troponin Cutoffs for Ruling Out Acute Myocardial Infarction

Comparison of Troponin Assay With New POCT Method in the Decision-making Pathway of Patient With Chest Pain Suspected of Acute Myocardial Ischemia in Emergency Room (POCT)

Troponin POCT in the Diagnosis of an Acute Myocardial Infarction

Detailed Description

Conditions

Study Design

Study Groups

TriageTrue hs-cTnI 0/1-hour algorithm

QuidelOrthos TriageTrue hs-cTnI whole-blood assay

Interventions

QuidelOrthos TriageTrue hs-cTnI whole-blood assay

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Norwegian Health Association

Oslo University Hospital

QuidelOrtho

Vestre Viken Hospital Trust

The Dam Foundation

Amsterdam UMC

Sørlandet Hospital

University of Oslo

Responsible Party

Tonje R. Johannessen

Locations

Lyngen Emergency Primary Care Centre

Alta Emergency Primary Care Centre

Drammen Emergency Primary Care Centre

Fredrikstad and Hvaler Emergency Primary Care Centre

Oslo Accident and Emergency Outpatient Clinic

Trondheim Intermunicipal Emergency Primary Care Centre

Countries

Central Contacts

Tonje R. Johannessen, MD, PhD

Odd Martin Vallersnes, Professor

Facility Contacts

Bent Håkan Lindberg, MD, PhD

Anne H. Davidsen, MD, PhD student

Marthe H. Prytz, MD

Simon Andrup, MD, PhD student

Tonje R. Johannessen, MD, PhD

Bjarne Austad, MD, PhD

References

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.

Related Links

Other Identifiers

SDAM_FOR555568

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