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| Name | Class |
|---|---|
| Maastricht Universitair Medisch Centrum | UNKNOWN |
| VieCuri Medical Centre | OTHER |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical decision rule | Experimental | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | A trial-based cost analysis and a cost-utility analysis (costs per QALY, assessed using the EQ-5D-5L questionnaire) | 6 months |
| Adherence to the recommendations of the clinical decision rule by general practitioners (GP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Bonten, MD PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2300 RC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37290947 | Derived | 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. |
| Label | URL |
|---|---|
| Up to date information about the study for patients and general practitioners (Dutch) | View source |
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Individual participant data that underlie the results reported in the main article, after deidentification (text, tables, figures and appendices)
Beginning 3 months and ending 5 years following main article publication
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.
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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.
| 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. | 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) | 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. | 6 weeks after inclusion |
| Subgroup analyses for hospital referral rate for acute chest pain | Subgroups are classified by
| 24 hours after inclusion |
| Subgroup analyses for hospital referral rate for acute chest pain | Subgroups are classified by
| 6 weeks after inclusion |
| Subgroup analyses for diagnostic accuracy of the clinical decision rule | Subgroups are classified by
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. | 24 hours after inclusion |
| Subgroup analyses for diagnostic accuracy of the clinical decision rule | Subgroups are classified by
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. | 6 weeks after inclusion |
| Subgroup analyses for diagnostic accuracy of the clinical decision rule | Subgroups are classified by
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. | 6 months after inclusion |
| Original registration on www.NTR.nl before start of the study | View source |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |