Point-of-Care Troponin Testing in the Emergency Department

NCT06845826 | Recruiting

• 1 other identifier: S68277
• Study Type: interventional
• Target: 1,552
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate whether a POC-guided testing strategy to exclude non-ST elevation myocardial infarction (NSTEMI) in acute chest pain patients presenting at the emergency department (ED) can result in a shorter length of stay compared to the routine central laboratory testing strategy. Currently, most often two high-sensitivity troponin (hs-cTn) tests are required for exclusion of NSTEMI, and central laboratories are struggling to achieve the recommended turnaround time of 60 minutes. Novel POC hs-cTn testing technology can provide results in minutes, potentially reducing the ED length of stay. This may lead to a reduction in ED crowding, which is a growing worldwide healthcare problem, resulting in poorer patient outcomes. This study may therefore improve patient burden, ED staff workload, and lead to more efficient expenditure of healthcare resources. We will perform a prospective, cross-sectional, interventional, single-center, open label, randomized trial. All consecutive patients older than 18 years and younger than 75 years presenting at the UZ Leuven emergency department with chest pain or chest pain-equivalent symptoms suspected of an acute coronary syndrome (ACS) will be invited to participate in the study. After informed consent patients will be randomized into the point-of-care testing (POCT) group or the usual care group. Patients in the POCT group will undergo the novel POC test-guided strategy. In the POC strategy the first hs-cTnI test shortly after admission to the ED will be performed on the POC Atellica VTLi. The second test will be performed with the usual central laboratory hs-cTnT test. Patients in the usual care group will undergo the usual testing strategy with one or two hs-cTnT tests performed in the hospital's central laboratory.

Conditions

Acute Coronary Syndromes

Keywords

POCT; troponine testing; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Length of stay at emergency department

  with a tracking bracelet we measure the time of presentation until discharge of the patient in the emergency department

  Hours: 24

Secondary Outcomes (1)

• 30-day MACE

  Day: 30

Other Outcomes (5)

• Degree of user friendliness: questionnaires and qualitative think aloud sessions

  Hours: 24

• Phyisican adherence

  Hours: 24

• Patient satisfaction

  Day: 7

Study Arms (2)

Usual care

NO INTERVENTION

care as usual: central laboratory troponine testing

Intervention

ACTIVE COMPARATOR

To establish in a randomized interventional controlled trial whether a novel POC test-guided strategy in acute chest pain patients in the ED results in a reduced length of stay compared to the usual central laboratory testing strategy when managing patients with a suspicion of NSTEMI

Device: Point-of-Care high-sensitivity troponin testing

Interventions

Point-of-Care high-sensitivity troponin testing DEVICE

To establish in a randomized interventional controlled trial whether a novel POC test-guided strategy in acute chest pain patients in the ED results in a reduced length of stay compared to the usual central laboratory testing strategy when managing patients with a suspicion of NSTEMI

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

KU/ UZ Leuven ED

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jan YJ Verbakel, MD, PhD, Professor

  Leuven Unit for Health Technology Assessment Research, University of Leuven

  STUDY DIRECTOR

Central Study Contacts

Tine De Burghgraeve, PhD

CONTACT

+3216377276; tine.deburghgraeve@kuleuven.be

David Bos, PhD student, MD

CONTACT

david.bos@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, cross-sectional, interventional, single-center, open label, randomized trial

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 25, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

BE (1)