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)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care

• Troponin testing requested by the treating physician

Locations
Other Locations
Norway
Alta Emergency Primary Care Centre
NOT_YET_RECRUITING
Alta
Drammen Emergency Primary Care Centre
NOT_YET_RECRUITING
Drammen
Fredrikstad and Hvaler Emergency Primary Care Centre
NOT_YET_RECRUITING
Fredrikstad
Lyngen Emergency Primary Care Centre
RECRUITING
Lyngseidet
Oslo Accident and Emergency Outpatient Clinic
RECRUITING
Oslo
Trondheim Intermunicipal Emergency Primary Care Centre
NOT_YET_RECRUITING
Trondheim
Contact Information
Primary
Tonje R. Johannessen, MD, PhD
t.r.johannessen@medisin.uio.no
+47 95169272
Backup
Odd Martin Vallersnes, Professor
o.m.vallersnes@medisin.uio.no
Time Frame
Start Date: 2025-06-27
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 2500
Treatments
Other: 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).
Related Therapeutic Areas
Sponsors
Collaborators: Vestre Viken Hospital Trust, Sørlandet Hospital, Oslo University Hospital, Amsterdam UMC, Norwegian Health Association, The Dam Foundation, QuidelOrtho
Leads: University of Oslo

This content was sourced from clinicaltrials.gov