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

NCT05827237 | Completed DMC

• 1 other identifier: p20.013
• Study Type: interventional
• Target: 946
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Chest Pain; Myocardial Infarction; Acute Coronary Syndrome

Keywords

Chest pain; Primary care; General practice; Myocardial infarction; Troponin; Point of care test

Outcome Measures

Primary Outcomes (5)

• Hospital referral rate for acute chest pain

  hospital referral rate for acute chest pain compared between intervention and control group

  24 hours after inclusion

• Hospital referral rate for acute chest pain

  hospital referral rate for acute chest pain compared between intervention and control group

  6 weeks after inclusion

• Diagnostic accuracy of the clinical decision rule

  Diagnostic accuracy (i.e. sensitivity, negative predictive value) for Acute Coronary Syndrome (ACS) and major adverse cardiac events (MACE). MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.

  24 hours after inclusion

• Diagnostic accuracy of the clinical decision rule

  Diagnostic accuracy (i.e. sensitivity, negative predictive value) for ACS and major adverse cardiac events (MACE) MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.

  6 weeks after inclusion

• Diagnostic accuracy of the clinical decision rule

  Diagnostic accuracy (i.e. sensitivity, negative predictive value) for ACS and major adverse cardiac events (MACE) MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.

  6 months after inclusion

Secondary Outcomes (10)

• Cost-effectiveness

  6 months

• Adherence to the recommendations of the clinical decision rule by general practitioners (GP)

  24 hours after inclusion

• Patient reassurance measured by the State-Trait Anxiety Inventory

  1 week after inclusion

• Diagnostic accuracy of the gut feeling/ presence of a sense of alarm from general practitioners

  6 weeks after inclusion

• Diagnostic accuracy of the HEART-score

  6 weeks after inclusion

Study Arms (2)

Clinical decision rule

EXPERIMENTAL

Patients in whom the clinical decision rule is used to exclude acute coronary syndrome

Diagnostic Test: Clinical decision rule

Standard care

NO INTERVENTION

Patients in whom the general practitioner decides upon referral following local guidelines.

Interventions

Clinical decision rule DIAGNOSTIC_TEST

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

Clinical decision rule

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age
• Acute chest pain
• Seen by general practitioner

You may not qualify if:

• \<1 hour since onset of symptoms
• Inability to speak or understand Dutch
• Hemodynamic instability

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Maastricht Universitair Medisch Centrum: collaborator
• VieCuri Medical Centre: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2300 RC, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37290947 DERIVED

Related Links

• Up to date information about the study for patients and general practitioners (Dutch)
• Original registration on www.NTR.nl before start of the study

MeSH Terms

Conditions

Chest Pain; Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Tobias Bonten, MD PhD

  LUMC

  PRINCIPAL INVESTIGATOR

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: Assistant professor

Model Details: A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 25, 2023
• Study Start: August 18, 2021
• Primary Completion: February 5, 2025
• Study Completion: April 23, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following main article publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

NL (1)