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NCT06853626Active, not recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
2500 (actual)
First submitted
20 Feb 2025
Start date
27 Jun 2025
Primary completion date
1 Jun 2026
Lead sponsor
University of Oslo
NCT number
NCT06853626

What you commit to

  • Study type: Interventional
  • Participants enrolled: 2500
  • From 27 Jun 2025 to the primary completion date, 1 Jun 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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)

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Alta Emergency Primary Care Centre
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AltaNorwayUnknown status
Drammen Emergency Primary Care Centre
Coordinator of this site? Confirm its status
DrammenNorwayUnknown status
Fredrikstad and Hvaler Emergency Primary Care Centre
Coordinator of this site? Confirm its status
FredrikstadNorwayUnknown status
Lyngen Emergency Primary Care Centre
Coordinator of this site? Confirm its status
LyngseidetNorwayUnknown status
Oslo Accident and Emergency Outpatient Clinic
Coordinator of this site? Confirm its status
OsloNorwayUnknown status
Trondheim Intermunicipal Emergency Primary Care Centre
Coordinator of this site? Confirm its status
TrondheimNorwayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.