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Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT

NCT05827237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 946

Last updated 2025-09-10

No results posted yet for this study

Summary

The goal of this clustered, diagnostic randomized controlled trial is to study a clinical decision rule including a high-sensitive troponin I point of care test in patients with chest pain in primary care.

The main questions it aims to answer are:

1. Can unnecessary referrals to secondary care be reduced by the use of a clinical deci-sion rule in patients with new onset, non-traumatic chest pain in primary care? Compared to current daily practice.
2. What is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months?

Conditions

Interventions

DIAGNOSTIC_TEST

Clinical decision rule

Clinical decision rule for acute chest pain, consisting of the Marburg Heart Score (5 questions) combined with a high-sensitive troponin I point of care test

Sponsors & Collaborators

  • Maastricht Universitair Medisch Centrum

    collaborator UNKNOWN

  • VieCuri Medical Centre

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Tobias Bonten, MD PhD · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2025-02-05
Completion
2025-04-23

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05827237 on ClinicalTrials.gov