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Recruiting Observational

Prehospital Point-of-Care Hs-Troponin I for Rule-Out of Acute Myocardial Infarction in Patients Without ST-Segment Elevation

NCT07563998 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2026-07-01
Last updated
2026-09-02

Condition(s) studied

Myocardial Infarction (MI)Acute Coronary Syndromes (ACS)

Investigational drug(s) / intervention(s)

Prehospital high-sensitivity cardiac troponin I measurement

Prehospital high-sensitivity cardiac troponin I measurement: Prehospital measurement of high-sensitivity cardiac troponin I (hs-TnI) using a point-of-care device during routine emergency medical services (EMS) assessment. Blood samples are analyzed according to manufacturer instructions and local procedures. The test is performed for research purposes only, and results are not available for clinical decision-making and do not influence patient management.

Study summary

People who call emergency medical services (EMS) with chest pain or other possible heart-related symptoms are often taken to hospital for further testing. However, only a small proportion of these patients are ultimately diagnosed with a serious heart condition such as a heart attack. This means that many patients undergo hospital transport and evaluation even though their risk is low.

In hospitals, a blood test called high-sensitivity cardiac troponin is commonly used to help diagnose or rule out heart attacks. It is not yet well established whether this type of test can be used safely and effectively earlier, in the prehospital setting.

This study will investigate whether it is feasible to measure high-sensitivity troponin in the ambulance and how well the test can identify patients at low risk of serious heart conditions. A small blood sample will be taken as part of routine care and analyzed using a portable device. The test result will not be used to guide treatment or decisions during the study.

The study will assess how well the test predicts heart-related events within 30 days and how practical it is to perform the test in real-life emergency settings. The results may help guide future research on how to improve early assessment and decision-making for patients with suspected heart disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older * Assessed by one of the participating EMS units equipped for POCT sampling * Presentation with symptoms suggestive of acute coronary syndrome * Planned transport to hospital for further evaluation Exclusion Criteria: * ST-segment elevation on prehospital electrocardiogram * Clinical condition requiring immediate life-saving intervention precluding study procedures * Interhospital transport * Prior inclusion in the study within 30 days

Primary outcome measure(s)

  • Major adverse cardiac events (MACE) within 30 days — 30 days
    Composite outcome including acute myocardial infarction, coronary revascularization, or cardiovascular death within 30 days of the index emergency medical services contact.

Trial sites (1)

FacilityCityRegionStatus
Prehospital Emergency Medical Services, Central Denamrk Region Aarhus N Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563998 on ClinicalTrials.gov ↗ ← All trials in Denmark