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| Name | Class |
|---|---|
| Norwegian Health Association | OTHER |
| Oslo University Hospital | OTHER |
| QuidelOrtho | INDUSTRY |
| Vestre Viken Hospital Trust |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuidelOrthos TriageTrue hs-cTnI whole-blood assay | Diagnostic Test | Already described |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | At baseline and repeated after 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency | The proportion of patients finished triaged as rule-out or rule-in by the protocol at index | Baseline |
| Total number of hospital referrals at index | Proportion of patients being directly hospitalised at index |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the TriageTrue hs-cTnI whole-blood assay and clinical risk scores | Pre-planned subanalyses to evaluate the performance of various clinical risk scores integrating a single hs-cTnI POC measurement (incl. the History, Electrocardiogram, Age, Risk factors, and Troponin (HEART) score and the Troponin-only Manchester Acute Coronary Symdrome (T-MACS) score). | From baseline to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyngen Emergency Primary Care Centre | Lyngseidet | Lyngen | Norway | |||
| Alta Emergency Primary Care Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40058362 | Result | 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. | |
| 40418919 | Result | Johannessen 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. |
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| OTHER |
| The Dam Foundation | OTHER |
| Amsterdam UMC | OTHER |
| Sorlandet Hospital HF | OTHER_GOV |
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.
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| Baseline |
| Total length of stay | Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge) | 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 | From baseline to 1 year |
| PROM: Cardiac Anxiety | Changes in cardiac-related anxiety, measured by the Cardiac Anxiety Questionnaire (CAQ) | At baseline and repeated after 90 days |
| PROM: Depression | Changes in depression, measured by the Patient Health Questionnaire-4 (PHQ-4) | At baseline and repeated after 90 days |
| PROM: Insomnia | Changes in sleep disturbances, measured by the Sleep Condition Indicator-02 | 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 | 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) | From baseline to 1 year |
| Societal costs | Proportion of production loss/sick leave due to chest pain-related diagnoses | 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 | 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. | From baseline to 1 year |
| Alta |
| Norway |
| Drammen Emergency Primary Care Centre | Drammen | Norway |
| Fredrikstad and Hvaler Emergency Primary Care Centre | Fredrikstad | Norway |
| Oslo Accident and Emergency Outpatient Clinic | Oslo | Norway |
| Trondheim Intermunicipal Emergency Primary Care Centre | Trondheim | Norway |
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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