Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT
NCT ID: NCT05827237
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
946 participants
INTERVENTIONAL
2021-08-18
2025-04-23
Brief Summary
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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?
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Detailed Description
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An independent endpoint committee consisting of a cardiologist and general practitioner will adjudicate the final diagnosis. Primary endpoints are ACS and Major Adverse Cardiac Events. A delayed reference standard of 6 months will be used.
For high sensitive troponin I measurement, the Siemens Atellica VTLi immunoassay analyser is used.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Clinical decision rule
Patients in whom the clinical decision rule is used to exclude acute coronary syndrome
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
Standard care
Patients in whom the general practitioner decides upon referral following local guidelines.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Acute chest pain
* Seen by general practitioner
Exclusion Criteria
* Inability to speak or understand Dutch
* Hemodynamic instability
18 Years
ALL
No
Sponsors
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Maastricht Universitair Medisch Centrum
UNKNOWN
VieCuri Medical Centre
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Tobias N Bonten, MD PhD
Assistant professor
Principal Investigators
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Tobias Bonten, MD PhD
Role: PRINCIPAL_INVESTIGATOR
LUMC
Locations
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Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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References
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van den Bulk S, Petrus AHJ, Willemsen RTA, Boogers MJ, Meeder JG, Rahel BM, van den Akker-van Marle ME, Numans ME, Dinant GJ, Bonten TN. Ruling out acute coronary syndrome in primary care with a clinical decision rule and a capillary, high-sensitive troponin I point of care test: study protocol of a diagnostic RCT in the Netherlands (POB HELP). BMJ Open. 2023 Jun 8;13(6):e071822. doi: 10.1136/bmjopen-2023-071822.
Related Links
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Up to date information about the study for patients and general practitioners (Dutch)
Original registration on www.NTR.nl before start of the study
Other Identifiers
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p20.013
Identifier Type: -
Identifier Source: org_study_id
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