Chest PainPOB HELPNCT05827237
Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT
A study testing Clinical decision rule in people with Chest Pain and Myocardial Infarction, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- Clinical decision rule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 946 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Aug 2021to 23 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Acute chest pain
- Seen by general practitioner
Who cannot join
- <1 hour since onset of symptoms
- Inability to speak or understand Dutch
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2300 RC
About this study
Official 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
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:
- 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.
- What is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months?
Read the detailed description
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.
- Conditions
- Chest Pain, Myocardial Infarction, Acute Coronary Syndrome
- Being tested
- Clinical decision rule
- Keywords
- Chest pain, Primary care, General practice, Myocardial infarction, Troponin, Point of care test
- Medical subject headings
- Chest Pain, Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision ruleDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Clinical decision rule | Experimental | Patients in whom the clinical decision rule is used to exclude acute coronary syndrome Receives: Diagnostic Test: Clinical decision rule |
| Standard care | No intervention | Patients in whom the general practitioner decides upon referral following local guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital referral rate for acute chest pain
hospital referral rate for acute chest pain compared between intervention and control group
Measured: 24 hours after inclusion
Hospital referral rate for acute chest pain
hospital referral rate for acute chest pain compared between intervention and control group
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after inclusion
Secondary outcomes (10)
Cost-effectiveness
A trial-based cost analysis and a cost-utility analysis (costs per QALY, assessed using the EQ-5D-5L questionnaire)
Measured: 6 months
Adherence to the recommendations of the clinical decision rule by general practitioners (GP)
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.
Measured: 24 hours after inclusion
Patient reassurance measured by the State-Trait Anxiety Inventory
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.
Measured: 1 week after inclusion
Diagnostic accuracy of the gut feeling/ presence of a sense of alarm from general practitioners
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)
Measured: 6 weeks after inclusion
Diagnostic accuracy of the HEART-score
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.
Measured: 6 weeks after inclusion
Subgroup analyses for hospital referral rate for acute chest pain
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)
Measured: 24 hours after inclusion
Subgroup analyses for hospital referral rate for acute chest pain
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)
Measured: 6 weeks after inclusion
Subgroup analyses for diagnostic accuracy of the clinical decision rule
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.
Measured: 24 hours after inclusion
Subgroup analyses for diagnostic accuracy of the clinical decision rule
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.
Measured: 6 weeks after inclusion
Subgroup analyses for diagnostic accuracy of the clinical decision rule
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.
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start18 Aug 2021
- Primary completion5 Feb 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.
- Masking
- None (open label)
- Enrolment
- 946 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht Universitair Medisch Centrum, VieCuri Medical Centre, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Tobias N Bonten, MD PhD, Leiden University Medical Center
- Investigators
- Tobias Bonten, MD PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827237
- Sponsor's protocol ID
- p20.013
- Acronym
- POB HELP
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the main article, after deidentification (text, tables, figures and appendices)
Publications
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.
PubMed 37290947
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05827237
- Acronym / sponsor ID
- POB HELP / p20.013
- Conditions
- Chest Pain, Myocardial Infarction, Acute Coronary Syndrome
- Keywords
- Chest pain, Primary care, General practice, Myocardial infarction, Troponin, Point of care test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht Universitair Medisch Centrum, VieCuri Medical Centre, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- What is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months?
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Clinical decision rule | Experimental | Diagnostic Test: Clinical decision rulePatients in whom the clinical decision rule is used to exclude acute coronary syndrome |
| Standard care | No intervention | –Patients in whom the general practitioner decides upon referral following local guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- Acute chest pain
- Seen by general practitioner
Key exclusion criteria (3 listed)
- <1 hour since onset of symptoms
- Inability to speak or understand Dutch
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision ruleClinical 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 | Diagnostic test | Clinical decision rule |
Primary outcome
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
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
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.
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.
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.
10 secondary outcomes
Cost-effectiveness
Time frame: 6 months
Adherence to the recommendations of the clinical decision rule by general practitioners (GP)
Time frame: 24 hours after inclusion
Patient reassurance measured by the State-Trait Anxiety Inventory
Time frame: 1 week after inclusion
Diagnostic accuracy of the gut feeling/ presence of a sense of alarm from general practitioners
Time frame: 6 weeks after inclusion
Diagnostic accuracy of the HEART-score
Time frame: 6 weeks after inclusion
Subgroup analyses for hospital referral rate for acute chest pain
Time frame: 24 hours after inclusion
Subgroup analyses for hospital referral rate for acute chest pain
Time frame: 6 weeks after inclusion
Subgroup analyses for diagnostic accuracy of the clinical decision rule
Time frame: 24 hours after inclusion
Subgroup analyses for diagnostic accuracy of the clinical decision rule
Time frame: 6 weeks after inclusion
Subgroup analyses for diagnostic accuracy of the clinical decision rule
Time frame: 6 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 37290947van 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.
- Up to date information about the study for patients and general practitioners (Dutch)Link provided by the sponsor.
- Original registration on www.NTR.nl before start of the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the main article, after deidentification (text, tables, figures and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Bonten, MD PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision rule in people with Chest Pain and Myocardial Infarction, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital referral rate for acute chest pain (time frame: 24 hours after inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.