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| ID | Type | Description | Link |
|---|---|---|---|
| NTR7346 | Registry Identifier | Netherlands Trial Register | |
| NTR7346 | Registry Identifier | International Clinical Trials Registry Platform | |
| 852001942 | Other Grant/Funding Number | ZonMw |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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Patients with chest pain suspected for non ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is not necessary. The ARTICA trial aims to assess the healthcare cost reduction and safety of a pre-hospital rule-out strategy using a single POC troponin measurement.
Patients with chest pain suspected of a NSTE-ACS are screened by ambulance paramedics. The HEAR score (HEART score without the Troponin component) is assessed and patients with a HEAR score of ≤3 are included. The patients are randomised to 1) pre-hospital rule-out with POC troponin measurement (intervention group) and 2) direct transfer to the ED (standard care group). Primary outcome is healthcare costs after 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-hospital rule-out strategy | Experimental | Patients undergo a point-of-care troponin T measurement. If troponin is low, an acute coronary syndrome is considered ruled-out and the care for the patient is transferred to the general practitioner. If troponin is elevated, the patient is immediately transported to the emergency department. |
|
| Emergency department rule-out strategy | No Intervention | According to standard care, the patients are immediately transported to the emergency department. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-hospital rule-out strategy | Diagnostic Test | Point-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations) | Healthcare costs consist of all costs related to healthcare consumption | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: all cause death, acute coronary syndrome, unplanned revascularisation | Major adverse cardiac events (all cause death, ACS, unplanned revascularisation) | 30 days |
| Costs from a societal perspective (all health effects and changes in resource use caused by an intervention) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels van Royen, MD PhD Prof | Radboud University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Nijmegen | 6525GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38011992 | Derived | Aarts GWA, Camaro C, Rodwell L, Adang EMM, van Hout R, Brok G, Hoare A, de Pooter FPC, de Wit W, Cramer GE, van Kimmenade RRJ, Ouwendijk E, Rutten M, Zegers E, van Geuns RM, Gomes MER, Damman P, van Royen N. Differences in risk and costs between prehospital identified low-risk men and women with chest pain. Open Heart. 2023 Nov 27;10(2):e002390. doi: 10.1136/openhrt-2023-002390. | |
| 36755110 |
| Label | URL |
|---|---|
| Study website | View source |
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Data will be available to researchers who were granted permission to the data by the principal investigator
1 year after completion
After permission
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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The patients are randomised to 1) pre-hospital rule-out with POC troponin measurement (intervention group) and 2) direct transfer to the ED (standard care group).
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The clinical events are blindly adjudicated by an independent Clinical Events Committee
Costs from a societal perspective are defined as the sum of the healthcare costs and the costs from productivity losses. |
| 30 days |
| Safety (all cause death, acute coronary syndrome, unplanned revascularisation) | Major adverse cardiac events (all cause death, ACS, unplanned revascularisation) | 6 months |
| Safety (all cause death, acute coronary syndrome, unplanned revascularisation) | Major adverse cardiac events (all cause death, ACS, unplanned revascularisation) | 12 months |
| Derived |
| Camaro C, Aarts GWA, Adang EMM, van Hout R, Brok G, Hoare A, Rodwell L, de Pooter F, de Wit W, Cramer GE, van Kimmenade RRJ, Damman P, Ouwendijk E, Rutten M, Zegers E, van Geuns RM, Gomes MER, van Royen N. Rule-out of non-ST-segment elevation acute coronary syndrome by a single, pre-hospital troponin measurement: a randomized trial. Eur Heart J. 2023 May 14;44(19):1705-1714. doi: 10.1093/eurheartj/ehad056. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |