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Completed

NCT Number: NCT05827237

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

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?

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Key information

Conditions

Chest Pain Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, 2300 RC, Netherlands

About this study

This clustered, diagnostic randomized controlled trial will included patients with acute chest pain consulting their general practitioner. Practices in the intervention group will use a clinical decision rule consisting of the Marburg Heart Score and a high-sensitive troponin I point of care test to exclude acute coronary syndrome (ACS) and decide upon referral. Practices in the control group will apply usual care following local guidelines.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Hospital referral rate for acute chest pain

    Time frame: 24 hours after inclusion

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

  2. Hospital referral rate for acute chest pain

    Time frame: 6 weeks after inclusion

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

  3. Diagnostic accuracy of the clinical decision rule

    Time frame: 24 hours after inclusion

    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.

  4. Diagnostic accuracy of the clinical decision rule

    Time frame: 6 weeks after inclusion

    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.

  5. Diagnostic accuracy of the clinical decision rule

    Time frame: 6 months after inclusion

    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.

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 6 months

    A trial-based cost analysis and a cost-utility analysis (costs per QALY, assessed using the EQ-5D-5L questionnaire)

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

    Time frame: 24 hours after inclusion

    Percentage of general practitioners following and deferring from the clinical decision rule, by comparing the GP's policy with the recommendations of the decision rule.

  3. Patient reassurance measured by the State-Trait Anxiety Inventory

    Time frame: 1 week after inclusion

    Reassurance of patients, using the State-Trait Anxiety Inventory after the index consultation.

    State-Trait Anxiety Inventory: consisting of 40 self-report items on a 4-point Likert scale (min. 20- max. 80 points). Higher scores are correlated with higher levels of anxiety.

    Compared between intervention and control group.

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

    Time frame: 6 weeks after inclusion

    Diagnostic accuracy (i.e. sensitivity, negative predictive value) of general practitioner's gut feeling for Acute Coronary Syndrome and major adverse cardiac events (MACE). Using the Gut Feeling Questionnaire (GFC).

    The questionnaire consists of 11 items. The items use a 5-point Likert scale: completely disagree to completely agree. Items 1 and 11 are the same and ask the physician about their gut feeling: alarm vs reassuring.

    A high score indicates a sense of alarm

    (From Barais M, Fossard E, Dany A, et al. Accuracy of the general practitioner's sense of alarm when confronted with dyspnoea and/or chest pain: a prospective observational study. BMJ Open. 2020;10(2):e03434)

  5. Diagnostic accuracy of the HEART-score

    Time frame: 6 weeks after inclusion

    Retrospectively for all patient with an ECG available for the occurrence of Acute Coronary Syndrome (ACS) and MACE.

    HEART-score assigning 0, 1 or 2 points to patient history, ECG abnormalities, Age, Cardiovascular risk factors and troponin. Lower score (0-3) indicates low risk for acute cardiac event.

    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. Subgroup analyses for hospital referral rate for acute chest pain

    Time frame: 24 hours after inclusion

    Subgroups are classified by

    • sex
    • region (Leiden, Maastricht, Venlo)
    • socio-economic status (using postal-code)
    • duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours)

  7. Subgroup analyses for hospital referral rate for acute chest pain

    Time frame: 6 weeks after inclusion

    Subgroups are classified by

    • sex
    • region (Leiden, Maastricht, Venlo)
    • socio-economic status (using postal-code)
    • duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours)

  8. Subgroup analyses for diagnostic accuracy of the clinical decision rule

    Time frame: 24 hours after inclusion

    Subgroups are classified by

    • sex
    • region (Leiden, Maastricht, Venlo)
    • socio-economic status (using postal-code)
    • duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours)

    For the occurrence of ACS and 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.

  9. Subgroup analyses for diagnostic accuracy of the clinical decision rule

    Time frame: 6 weeks after inclusion

    Subgroups are classified by

    • sex
    • region (Leiden, Maastricht, Venlo)
    • socio-economic status (using postal-code)
    • duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours)

    For the occurrence of ACS and 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.

  10. Subgroup analyses for diagnostic accuracy of the clinical decision rule

    Time frame: 6 months after inclusion

    Subgroups are classified by

    • sex
    • region (Leiden, Maastricht, Venlo)
    • socio-economic status (using postal-code)
    • duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours)

    For the occurrence of ACS and 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.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Maastricht Universitair Medisch Centrum
  • VieCuri Medical Centre
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Primary Care Decision Rule for Chest Pain Using the Marburg Heart Score and Hs-troponin I Point of Care Test to Rule Out Acute Coronary Syndrome

Acronym: POB HELP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2023
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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