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| ID | Type | Description | Link |
|---|---|---|---|
| NL71820.096.19 | Other Identifier | Toetsingonline/CCMO |
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| Name | Class |
|---|---|
| Siemens Healthineers Nederland B.V. | UNKNOWN |
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This is a multicenter, prospective, investigator-initiated, randomized controlled trial aiming to reduce the percentage of non-cardiac chest pain (NCCP) patients admitted to the cardiac emergency department (ED) by performing the modified HEART score by emergency medical transport (EMT) personnel.
Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly. However, referring all patients with chest pain is not feasible, as recent studies showed that up to 80% of the patients with acute chest pain do not have ACS.
Bedside point-of-care (POC) high sensitive troponin testing (in fingerprick blood/capillary blood) and the modified HEART score have become available and might play a substantial role in the triage and diagnosis of chest pain patients in a pre-hospital setting by general practitioners (GPs) and EMT personnel in the future. We hypothesize that patients with chest pain can be referred more accurately by using the modified HEART score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Chest pain patients in the intervention group will be assessed by EMT personnel by performing the modified HEART score (including POC high sensitive troponin-I measurement (POC HS cTnI)) and the referral policy depends on the result.
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| Control group | Active Comparator | Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified HEART score (including POC hs cTnI analysis) | Diagnostic Test | The modified HEART score was developed in 2007 and has been validated to stratify the risk of short-term adverse cardiac events in patients with chest pain at the ED. Negative predictive value (NPV) of the modified HEART score for ACS as well as positive predictive value (PPV) for major adverse cardiac events (MACE) within 6 weeks after presentation is high. The modified HEART score is an acronym for history, ECG, age, risk factors and troponin at arrival.The components can be rated 0,1 or 2 points each and result in a total score between 0 and 10. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %) | Evaluation of the percentage of NCCP patients admitted to the cardiac ED by performing the modified HEART score in comparison to our control group (regular triage and care). We aim to detect a reduction of minimal 10% in unnecessarily referred chest pain patients (NCCP patients) but expect an even higher percentage. A lower percentage of NCCP patients indicates improval of the triage of chest pain patients. | 30 days |
| The incidence of MACE (percentage, %) | The mortality and major adverse cardiovascular events (MACE) i.e. acute myocardial infarction, non-elective percutaneous coronary intervention, coronary artery bypass grafting or all cause death within 30 days, 6 months and 1 year after initial presentation in the intervention group versus control group. We aim that the proportion of MACE in the intervention group (modified HEART score) is non-inferior to the control group (regular care and triage). Preliminary results of the second phase of FAMOUS Triage trial showed 15.7% (13.1-18.6) MACE rate.We used the expected incidence of 15.7% as the point estimate (meaning no difference between control and intervention). A higher MACE rate (%) in the intervention group suggests a worst outcome. | 30 days, 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of MACE in subgroups (percentage, %) | Prespecified subgroup analyses of primary outcomes will be performed for:
| 30 days, 6 months and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Frenk, Drs. | Contact | 0031773205555 | lfrenk@viecuri.nl |
| Name | Affiliation | Role |
|---|---|---|
| Braim Rahel, Dr. | Viecuri Medical Centre Northern Limburg | Principal Investigator |
| Joan Meeder, Dr. | Viecuri Medical Centre Northern Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laurentius Hospital Roermond | Recruiting | Roermond | Limburg | 6043 CV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39806626 | Derived | Frenk LDS, Rahel BM, de Vos CB, van Osch FHM, Prestigiacomo FG, Janssen MJW, Willemsen RTA, van 't Hof AW, Meeder JG. Improving the accUracy of Referrals to the emerGency departmEnt of patieNts with chesT pain using the modified HEART score in Emergency Medical Transport (URGENT 2.0): protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Dec 20;14(12):e084139. doi: 10.1136/bmjopen-2024-084139. |
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It concerns an investigator initiated prospective 1:1 randomised clinical trial in chest pain patients in a pre-hospital setting. Patients will be randomised to (A, intervention group) a direct assessment of the modified HEART score (including POC high sensitive troponin measurement) by EMT personnel and refrainment of transport to the cardiac emergency department (ED) in cases of a low score or (B, control group) regular triage and hospital evaluation, taking place at the cardiac ED in the majority of cases.
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EMT personnel will be blinded for the randomisation sequence.
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| Standard care and triage according to the local (EMT)protocol. | Other | Standard care and triage of chest pain patients according to the local (EMT)protocol. |
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| The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %) | Prespecified subgroup analyses of primary outcomes will be performed for:
| 30 days, 6 months and 1 year |
| Cost-effectiveness analysis | This economic evaluation investigates the health care costs of full implementation of a prehospital rule- out strategy with the modified HEART score (intervention group) compared with regular care and standard transfer to the hospital to rule out ACS (control group). Health-care costs will be prospectively recorded at baseline and at 30 days follow-up, 6 months and 1 year. This includes health care costs due to readmission, diagnostic testing, revascularization etc. The cost of hospital treatment is determined by the Dutch Diagnose Behandel Combinatie (DBC) hospital reimbursement system and the DBC information system, similar to the international diagnosis related group system. | 30 days, 6 months and 1 year |
| Assessment of the diagnostic value of the modified HEART score. | Positive Predictive Value (PPV), sensitivity, specificity and Negative Predictive Value (NPV) of the modified HEART score for ACS will be calculated. | 30 days, 6 months and 1 year |
| Overview of the actual diagnosis of patients with a low modified HEART score (0-3). | To evaluate the percentage of patients in this specific group with ACS versus no-ACS. | 30 days |
| Overview of the actual diagnosis of patients with moderate-high modified HEART score (>3). | To evaluate the percentage of patients in this specific group with ACS versus no-ACS. | 30 days |
| Clinical accuracy POC hs cTnI. | Clinical accuracy (Positive Predictive value) of POC hs cTnI assessment versus hs cTnT at the cardiac ED. | 30 days |
| Time analysis. | Time elapsed from arrival EMT at patient's home to arrival at ED in intervention group versus control group. | 30 days |
| Cees de Vos, Dr. |
| Laurentius Hospital Roermond |
| Principal Investigator |
| Arnoud van 't Hof, Prof. dr. | Zuyderland MC | Study Director |
| Robert Willemsen, Dr. | General practitioner office Nazareth Maastricht | Study Director |
| Viecuri Medical Centre Northern Limburg | Recruiting | Venlo | Limburg | 5912 BL | Netherlands |
|
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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