Acute Myocardial Infarction (AMI)OUT-POCNCT06853626
One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care
A study testing QuidelOrthos TriageTrue hs-cTnI whole-blood assay in people with Acute Myocardial Infarction (AMI) and Chest Pain, run by University of Oslo at 6 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Chest Pain, Acute Coronary Syndromes (ACS)
- What is being tested?
- QuidelOrthos TriageTrue hs-cTnI whole-blood assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 6 sitesNorway
- Study dates
- 27 Jun 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care
- Troponin testing requested by the treating physician
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Alta Emergency Primary Care Centre
Alta
Drammen Emergency Primary Care Centre
Drammen
Fredrikstad and Hvaler Emergency Primary Care Centre
Fredrikstad
Lyngen Emergency Primary Care Centre
Lyngseidet, Lyngen
Oslo Accident and Emergency Outpatient Clinic
Oslo
Trondheim Intermunicipal Emergency Primary Care Centre
Trondheim
About this study
Official title: 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)
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.
Read more
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.
- Conditions
- Acute Myocardial Infarction (AMI), Chest Pain, Acute Coronary Syndromes (ACS), Non-cardiac Chest Pain, Troponin, Point of Care Testing
- Being tested
- QuidelOrthos TriageTrue hs-cTnI whole-blood assay
- Keywords
- TriageTrue, POC, hs-cTnI, 0/1-hour algorithm, troponin, chest pain, primary care, OOH, out-of-hours, acute myocardial infarction, point-of-care, OUT-POC, QuidelOrtho
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuidelOrthos TriageTrue hs-cTnI whole-blood assayDiagnostic test
Already described
| Study group | Role | What they receive |
|---|---|---|
| TriageTrue hs-cTnI 0/1-hour algorithm | Other | 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). Receives: Diagnostic Test: QuidelOrthos TriageTrue hs-cTnI whole-blood assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of acute myocardial infarctions at the index episode
Proportion of acute myocardial infarction at baseline, to assess the predictive performance of the TriageTrue 0/1-hour algorithm (incl. safety and accuracy) at index
Measured: From baseline to 30 days
PROM: Health-related quality of life
Differences in health-related quality of life among chest pain participants will be assessed through self-reported EQ-5D questionnaire with five levels (EQ-5D-5L) incl. the EQ-5D visual analogue scale (EQ VAS).
Measured: At baseline and repeated after 90 days
Secondary outcomes (12)
Efficiency
The proportion of patients finished triaged as rule-out or rule-in by the protocol at index
Measured: Baseline
Total number of hospital referrals at index
Proportion of patients being directly hospitalised at index
Measured: Baseline
Total length of stay
Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge)
Measured: Baseline to 24 hours
Composite of acute MI and all-cause death
To assess the prognostic performance of the algorithm after 30, 90, and 365 days
Measured: From baseline to 1 year
PROM: Cardiac Anxiety
Changes in cardiac-related anxiety, measured by the Cardiac Anxiety Questionnaire (CAQ)
Measured: At baseline and repeated after 90 days
PROM: Depression
Changes in depression, measured by the Patient Health Questionnaire-4 (PHQ-4)
Measured: At baseline and repeated after 90 days
PROM: Insomnia
Changes in sleep disturbances, measured by the Sleep Condition Indicator-02
Measured: At baseline and repeated after 90 days
PROM: Burden of chest pain
Changes in chest pain frequency, avoidance, intensity and duration, measured by Jonsbu's questionnaire
Measured: At baseline and repeated after 90 days
Incremental cost-effectiveness ratio
Difference in quality-adjusted life-years by using the OUT-POC protocol compared to standard care (control)
Measured: From baseline to 1 year
Societal costs
Proportion of production loss/sick leave due to chest pain-related diagnoses
Measured: From baseline to 1 year
Healthcare utilization
Total number and type of treatment and follow-up in primary and secondary care due to chest pain-related diagnoses
Measured: From baseline to 1 year
Healthcare costs
Total costs of assessing patients with chest pain in emergency primary care by using the protocol compared to usual care (control), including unit costs per treatment, visit, stay.
Measured: From baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start27 Jun 2025
- Primary completion1 Jun 2026
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, investigator-initiated pre-post intervention study aiming to evaluate implementation of the QuidelOrthos TriageTrue hs-cTnI whole-blood assay at six Norwegian (non-randomised) emergency primary care clinics. A control group will be identified to estimate the effect of the OUT-POC protocol. We will benefit from registry data to 1) estimate hospital referrals before the intervention in the same regions and 2) establish an external control group consisting of municipalities that are not using POC hs-cTn testing.
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Health Association, Oslo University Hospital, QuidelOrtho, Vestre Viken Hospital Trust, The Dam Foundation, Amsterdam UMC, Sorlandet Hospital HF
- Responsible party
- Principal investigator, Tonje R. Johannessen, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853626
- Sponsor's protocol ID
- SDAM_FOR555568
- Acronym
- OUT-POC
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johannessen TR, Vallersnes OM, Larstorp ACK, Halvorsen S, Atar D. One-Hour Troponin Using a High-Sensitivity Point-of-Care Assay in Emergency Primary Care: The OUT-POC Pilot Study. Cardiology. 2026;151(2):168-180. doi: 10.1159/000545127. Epub 2025 Mar 7.
PubMed 40058362Johannessen TR, Vallersnes OM, Larstorp ACK, Halvorsen S, Atar D. Authors' Response Letter - Expanding the Use of Point-of-Care hs-cTnI in Emergency Primary Care: Insights from the OUT-POC Pilot Study. Cardiology. 2025 May 22;151(3):1-3. doi: 10.1159/000546344. Online ahead of print. No abstract available.
PubMed 40418919
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06853626
- Acronym / sponsor ID
- OUT-POC / SDAM_FOR555568
- Conditions
- Acute Myocardial Infarction (AMI), Chest Pain, Acute Coronary Syndromes (ACS), Non-cardiac Chest Pain, Troponin, Point of Care Testing
- Keywords
- TriageTrue, POC, hs-cTnI, 0/1-hour algorithm, troponin, chest pain, primary care, OOH
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Norwegian Health Association, Oslo University Hospital, QuidelOrtho, Vestre Viken Hospital Trust, The Dam Foundation, Amsterdam UMC, Sorlandet Hospital HF
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, investigator-initiated pre-post intervention study aiming to evaluate implementation of the QuidelOrthos TriageTrue hs-cTnI whole-blood assay at six Norwegian (non-randomised) emergency primary care clinics. A control group will be identified to estimate the effect of the OUT-POC protocol. We will benefit from registry data to 1) estimate hospital referrals before the intervention in the same regions and 2) establish an external control group consisting of municipalities that are not using POC hs-cTn testing.
| Arm | Type | Receives |
|---|---|---|
| TriageTrue hs-cTnI 0/1-hour algorithm | Other | Diagnostic Test: QuidelOrthos TriageTrue hs-cTnI whole-blood assayStudy 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care
- Troponin testing requested by the treating physician
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuidelOrthos TriageTrue hs-cTnI whole-blood assayAlready described | Diagnostic test | TriageTrue hs-cTnI 0/1-hour algorithm |
Primary outcome
Total number of acute myocardial infarctions at the index episode
Time frame: From baseline to 30 days
Proportion of acute myocardial infarction at baseline, to assess the predictive performance of the TriageTrue 0/1-hour algorithm (incl. safety and accuracy) at index
PROM: Health-related quality of life
Time frame: At baseline and repeated after 90 days
Differences in health-related quality of life among chest pain participants will be assessed through self-reported EQ-5D questionnaire with five levels (EQ-5D-5L) incl. the EQ-5D visual analogue scale (EQ VAS).
12 secondary outcomes
Efficiency
Time frame: Baseline
Total number of hospital referrals at index
Time frame: Baseline
Total length of stay
Time frame: Baseline to 24 hours
Composite of acute MI and all-cause death
Time frame: From baseline to 1 year
PROM: Cardiac Anxiety
Time frame: At baseline and repeated after 90 days
PROM: Depression
Time frame: At baseline and repeated after 90 days
PROM: Insomnia
Time frame: At baseline and repeated after 90 days
PROM: Burden of chest pain
Time frame: At baseline and repeated after 90 days
Incremental cost-effectiveness ratio
Time frame: From baseline to 1 year
Societal costs
Time frame: From baseline to 1 year
Healthcare utilization
Time frame: From baseline to 1 year
Healthcare costs
Time frame: From baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Results publication: PubMed 40058362Johannessen TR, Vallersnes OM, Larstorp ACK, Halvorsen S, Atar D. One-Hour Troponin Using a High-Sensitivity Point-of-Care Assay in Emergency Primary Care: The OUT-POC Pilot Study. Cardiology. 2026;151(2):168-180. doi: 10.1159/000545127. Epub 2025 Mar 7.
- Results publication: PubMed 40418919Johannessen TR, Vallersnes OM, Larstorp ACK, Halvorsen S, Atar D. Authors' Response Letter - Expanding the Use of Point-of-Care hs-cTnI in Emergency Primary Care: Insights from the OUT-POC Pilot Study. Cardiology. 2025 May 22;151(3):1-3. doi: 10.1159/000546344. Online ahead of print. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuidelOrthos TriageTrue hs-cTnI whole-blood assay in people with Acute Myocardial Infarction (AMI) and Chest Pain, run by University of Oslo at 6 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of acute myocardial infarctions at the index episode (time frame: From baseline to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06853626, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.