QuidelOrthos TriageTrue hs-cTnI whole-blood assay
Diagnostic TestAlready described
NCT Number: NCT06853626
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lyngen Emergency Primary Care Centre, Lyngseidet, Lyngen, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Already described
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
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).
Time frame: Baseline
The proportion of patients finished triaged as rule-out or rule-in by the protocol at index
Time frame: Baseline
Proportion of patients being directly hospitalised at index
Time frame: Baseline to 24 hours
Total duration of the chest pain assessment at the clinic at index (i.e., time from arrival to discharge)
Time frame: From baseline to 1 year
To assess the prognostic performance of the algorithm after 30, 90, and 365 days
Time frame: At baseline and repeated after 90 days
Changes in cardiac-related anxiety, measured by the Cardiac Anxiety Questionnaire (CAQ)
Time frame: At baseline and repeated after 90 days
Changes in depression, measured by the Patient Health Questionnaire-4 (PHQ-4)
Time frame: At baseline and repeated after 90 days
Changes in sleep disturbances, measured by the Sleep Condition Indicator-02
Time frame: At baseline and repeated after 90 days
Changes in chest pain frequency, avoidance, intensity and duration, measured by Jonsbu's questionnaire
Time frame: From baseline to 1 year
Difference in quality-adjusted life-years by using the OUT-POC protocol compared to standard care (control)
Time frame: From baseline to 1 year
Proportion of production loss/sick leave due to chest pain-related diagnoses
Time frame: From baseline to 1 year
Total number and type of treatment and follow-up in primary and secondary care due to chest pain-related diagnoses
Time frame: From baseline to 1 year
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.
Time frame: From baseline to 1 year
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).
University of Oslo
Other
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)
Acronym: OUT-POC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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