One-Hour Troponin Using a High-Sensitivity Point-of-Care Assay in Emergency Primary Care: The OUT-POC Pilot Study.
Tonje R Johannessen, Odd Martin Vallersnes, Anne Cecilie K Larstorp...
https://pubmed.ncbi.nlm.nih.gov/40058362Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06853626
Improved Management of Acute Chest Pain in Emergency Primary Care Using the QuidelOrtho TriageTrue High-Sensitivity Point-of-Care Troponin Assay
Led by University of Oslo · Updated on 2025-12-10
2500
Participants Needed
6
Research Sites
156 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
Researchers are evaluating a new method to manage acute chest pain in emergency primary care settings, focusing on the use of a high-sensitivity point-of-care troponin test. This test aims to improve diagnosis and reduce unnecessary hospital referrals for chest pain, which is often not related to heart problems. The study is sponsored by the University of Oslo and involves 2,500 patients over 1.5 years. Participants will have a blood sample taken for testing with the QuidelOrtho TriageTrue hs-cTnI whole-blood assay. Physicians will use a specific 0/1-hour algorithm to interpret results and guide decisions. This approach will be compared to standard care to assess its clinical performance and impact on hospital referrals and healthcare use. During the study, participants will be monitored for acute myocardial infarction occurrences and quality of life changes, including psychological stress and anxiety, using validated questionnaires at baseline and after 90 days. Researchers will also track hospital referrals, length of stay, and healthcare costs up to one year. The total involvement includes initial testing and follow-up assessments to evaluate the new testing strategy's effect on patient outcomes and healthcare efficiency.
CONDITIONS
Brief 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
You may qualify if you...
- Patients 18 years or older with non-traumatic acute chest pain presenting in emergency primary care
- Troponin testing requested by the treating physician
You will not qualify if you...
- Acute STEMI requiring direct hospital referral
- Hemodynamically unstable patients requiring immediate hospital referral
- Unable to provide written informed consent due to time restraints, language barriers, cognitive impairment, or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to 1 hour
Participants have a venous blood sample taken for high-sensitivity troponin testing using the QuidelOrthos TriageTrue whole-blood point-of-care assay. The treating physician evaluates results using a specific 0/1-hour algorithm.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 1 year
Participants are followed for outcomes related to acute myocardial infarction, hospital referrals, and health-related quality of life over time.
Follow-up assessments at baseline, 30 days, 90 days, and 1 year
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
O
Odd Martin Vallersnes, Professor
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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Published Research Related To This Trial
Authors' Response Letter - Expanding the Use of Point-of-Care hs-cTnI in Emergency Primary Care: Insights from the OUT-POC Pilot Study.
Tonje R Johannessen, Odd Martin Vallersnes, Anne Cecilie K Larstorp...
https://pubmed.ncbi.nlm.nih.gov/40418919