Point-of-care high-sensitivity troponin testing in the emergency department

Point-of-Care High-Sensitivity Troponin Testing in the Emergency Department to Assess Myocardial Infarction for Timely Discharge

This trial tests whether point-of-care high-sensitivity troponin testing can shorten emergency department stays for adults under 75 who come in with chest pain suspected to be a non‑ST‑elevation heart attack.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1552 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: KU Leuven (Academic / other)
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT06845826 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, randomized, single-center interventional trial at KU Leuven comparing a point-of-care (POC) high-sensitivity troponin I strategy using the Atellica VTLi device to usual central laboratory high-sensitivity troponin T testing. Eligible adults aged 18–75 presenting within 12 hours of chest pain onset who are clinically stable and not STEMI are randomized to POC-guided testing (with central lab testing as a safety back-up) or to usual central lab testing alone. The POC test requires a 30–100 μL whole blood or plasma sample and delivers results in minutes to support early exclusion of NSTEMI, while all patients receive standard clinical assessment and ECG triage. The primary outcome is emergency department length of stay, with secondary interest in workflow, resource use, and patient/staff burden.

Who should consider this trial

Good fit: Adults 18–75 years old who present to the KU Leuven emergency department within 12 hours of chest pain onset, are hemodynamically stable, not a STEMI, and able to give informed consent.

Not a fit: Clinically unstable patients, confirmed STEMI patients, those older than 75 or with symptom onset beyond 12 hours (or symptom duration under 15 minutes), and patients transferred from other hospitals are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could reduce ED length of stay and crowding by enabling faster exclusion of NSTEMI and more efficient use of resources.

How similar studies have performed: Previous point-of-care troponin studies have shown mixed but sometimes promising reductions in ED stay, while high-sensitivity POC platforms such as the Atellica VTLi are relatively new and less extensively validated.

Eligibility criteria

Inclusion Criteria:

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures - At least 18 years of age at the time of signing the Informed Consent Form (ICF)
* Age \< 75 years of age
* Presenting with chest pain or chest pain-equivalent symptom suspect of acute coronary syndrome at the University Hospitals Leuven emergency department; Symptoms must have (had) a minimum duration of 15 minutes, and the current, ongoing episode of symptoms must have started within the past 12 hours.

Exclusion Criteria:

* Unable to provide written informed consent
* Age \<18 years or \>75 years
* Chest pain or equivalent symptom with a duration shorter than 15 minutes, or an onset of the current, ongoing episode of symptoms more than 12 hours ago
* Clinically unstable patients or confirmed STEMI patients, requiring immediate treatment
* Patients with recent chest trauma
* Patients transferred from another hospital
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CISP.

Where this trial is running

Leuven, Vlaams-Brabant

• KU/ UZ Leuven ED — Leuven, Vlaams-Brabant, Belgium (Recruiting)

Study contacts

• Study coordinator: Tine De Burghgraeve, PhD

Conditions Acute Coronary Syndromes; POCT; troponine testing; acute coronary syndrome