One-hour high-sensitivity point-of-care troponin test 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)
This will test whether a one-hour high-sensitivity point-of-care troponin blood test can quickly rule out heart attack in adults who come to primary emergency care with non-traumatic chest pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oslo Academic / other |
| Locations | 6 sites (Lyngseidet, Lyngen and 5 other locations) |
| Trial ID | NCT06853626 on ClinicalTrials.gov |
What this trial studies
The trial uses the QuidelOrtho TriageTrue high-sensitivity whole-blood troponin I assay with a 0/1-hour algorithm to triage adults presenting with non-traumatic chest pain in emergency primary care centers. Eligible participants (age 18+) who have troponin testing requested by their treating physician will have whole-blood hs-cTnI measured at presentation and again after one hour, and those results will guide rule-out versus hospital referral. Patients with STEMI or hemodynamic instability are excluded and sent directly to hospital care, and written informed consent is required. The study aims to see if point-of-care hs-cTnI can safely reduce unnecessary hospital referrals from primary emergency care.
Who should consider this trial
Good fit: Adults (18+) who present to participating emergency primary care centers with non-traumatic chest pain, for whom the treating physician requests troponin testing, and who can give written informed consent are ideal candidates.
Not a fit: Patients with an acute STEMI, haemodynamic instability, or those unable to provide written informed consent are not expected to benefit and will be referred for immediate hospital care.
Why it matters
Potential benefit: If successful, this could allow faster safe rule-out of heart attack at the primary care level, reducing unnecessary hospital referrals and speeding reassurance for patients.
How similar studies have performed: Hospital-based 0/1-hour high-sensitivity troponin algorithms have been shown to safely rule out myocardial infarction, but high-sensitivity point-of-care whole-blood assays are newer and have limited primary-care data.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lyngseidet, Lyngen and 5 other locations
- Lyngen Emergency Primary Care Centre — Lyngseidet, Lyngen, Norway (Recruiting)
- Alta Emergency Primary Care Centre — Alta, Norway (Recruiting)
- Drammen Emergency Primary Care Centre — Drammen, Norway (Recruiting)
- Fredrikstad and Hvaler Emergency Primary Care Centre — Fredrikstad, Norway (Recruiting)
- Oslo Accident and Emergency Outpatient Clinic — Oslo, Norway (Recruiting)
- Trondheim Intermunicipal Emergency Primary Care Centre — Trondheim, Norway (Recruiting)
Study contacts
- Study coordinator: Tonje R. Johannessen, MD, PhD
- Email: t.r.johannessen@medisin.uio.no
- Phone: +47 95169272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.