Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06845826

Point-of-Care Troponin Testing in the Emergency Department

Led by KU Leuven · Updated on 2026-03-18

1552

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

K

KU Leuven

Lead Sponsor

U

Universitaire Ziekenhuizen KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Point-of-Care Troponin Testing in the Emergency Department

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary written informed consent obtained before any screening procedures
  • Age between 18 and less than 75 years at the time of consent
  • Presenting with chest pain or equivalent symptoms suspected of acute coronary syndrome at the emergency department
  • Symptoms lasting at least 15 minutes
  • Current episode of symptoms started within the past 12 hours
Not Eligible

You will not qualify if you...

  • Unable to provide written informed consent
  • Age under 18 years or 75 years and older
  • Chest pain or equivalent symptoms lasting less than 15 minutes
  • Current episode of symptoms started more than 12 hours ago
  • Clinically unstable patients or confirmed STEMI patients needing immediate treatment
  • Recent chest trauma
  • Patients transferred from another hospital
  • Any condition that might jeopardize participant safety or compliance as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

KU/ UZ Leuven ED

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

T

Tine De Burghgraeve, PhD

CONTACT

D

David Bos, PhD student, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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