NCT06853626 One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care
| NCT ID | NCT06853626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oslo |
| Condition | Acute Myocardial Infarction (AMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,500 participants in total. It began in 2025-06-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06853626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myocardial Infarction (AMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06853626 currently recruiting?
Yes, NCT06853626 is actively recruiting participants. Contact the research team at t.r.johannessen@medisin.uio.no for enrollment information.
Where is the NCT06853626 trial being conducted?
This trial is being conducted at Lyngseidet, Norway, Alta, Norway, Drammen, Norway, Fredrikstad, Norway and 2 additional locations.
Who is sponsoring the NCT06853626 clinical trial?
NCT06853626 is sponsored by University of Oslo. The trial plans to enroll 2,500 participants.