Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06853626

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

Led by University of Oslo · Updated on 2025-12-10

2500

Participants Needed

6

Research Sites

235 weeks

Total Duration

On this page

Sponsors

U

University of Oslo

Lead Sponsor

N

Norwegian Health Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older with non-traumatic acute chest pain presenting in emergency primary care
  • Troponin testing requested by the treating physician
Not Eligible

You will not qualify if you...

  • Acute ST-elevation myocardial infarction (STEMI) requiring direct hospital referral
  • Hemodynamically unstable patients requiring direct hospital referral
  • Unable to provide written, informed consent due to time constraints, language barriers, impaired cognitive function, or other reasons

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Lyngen Emergency Primary Care Centre

Lyngseidet, Lyngen, Norway

Actively Recruiting

2

Alta Emergency Primary Care Centre

Alta, Norway

Actively Recruiting

3

Drammen Emergency Primary Care Centre

Drammen, Norway

Actively Recruiting

4

Fredrikstad and Hvaler Emergency Primary Care Centre

Fredrikstad, Norway

Actively Recruiting

5

Oslo Accident and Emergency Outpatient Clinic

Oslo, Norway

Actively Recruiting

6

Trondheim Intermunicipal Emergency Primary Care Centre

Trondheim, Norway

Actively Recruiting

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Research Team

T

Tonje R. Johannessen, MD, PhD

CONTACT

O

Odd Martin Vallersnes, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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