Pre-hospital Rule-out of Acute Coronary Syndrome

Not Applicable

• Conditions: Acute Coronary Syndrome
• Interventions: Diagnostic Test: Pre-hospital rule-out strategy

• Registration Number: NCT05466591
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2022-06-04
• Status Verified: 2022-07
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-20
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-25
• Study Completion: 2023-05-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 866

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-hospital rule-out strategy	Pre-hospital rule-out strategy	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.

Primary Outcome Measures

Name	Time	Method
Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)	30 days	Healthcare costs consist of all costs related to healthcare consumption

Secondary Outcome Measures

Name	Time	Method
Safety: all cause death, acute coronary syndrome, unplanned revascularisation	30 days	Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)	30 days	Costs from a societal perspective are defined as the sum of the healthcare costs and the costs from productivity losses.
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)	12 months	Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)

Trial Locations

Locations (1)

RadboudUMC; 🇳🇱 Nijmegen, Netherlands