Pre-hospital Rule-out of Acute Coronary Syndrome (ARTICA)

Acute Rule Out of Non ST-segment Elevation Acute Coronary Syndrome in the (Pre)Hospital Setting by HEART Score Assessment and a Single Point-of-care Troponin

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Pre-hospital rule-out strategy

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 Type: Interventional
• Enrollment (Actual): 866
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525GA
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Age at least 18 years; male ánd female
• All out-of-hospital patients with chest pain or symptoms suggestive of ACS initially visited by an ambulance with an indication for transfer to a hospital to evaluate and rule out ACS
• Symptom duration for at least two hours
• Modified HEAR(T) score less or equal than 3
• A point of care troponin below the upper reference limit (for patients stratified to pre-hospital management by the general practitioner)
• The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria:

• Electrocardiographic ST-segment elevation
• Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
• Patients in comatose state, defined as an Glascgow coma scale (GCS) <8
• Patients with known cognitive impairment
• Pregnancy or intention to become pregnant during the course of the study
• Patients presenting cardiogenic shock, defined as: systolic blood pressure <90 mmHg and heart rate >100 beats per minute and peripheral oxygen saturation <90% (without oxygen administration)
• Patients presenting with syncope
• Patients presenting with signs of heart failure
• Patients presenting with heart rhythm disorders and second or third degree atrioventricular block
• Patients with known end-stage renal disease (dialysis and/or glomular filtration rate (GFR) < 30 ml/min)
• Patients without a pre-hospital 12-lead ECG performed or available
• Patients suspicious of aortic dissection or pulmonary embolism
• Patients with confirmed acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting <30 days prior to inclusion
• Communication issues with patient/language barrier
• Decision of a present general practitioner to evaluate the patient at the emergency department (ED)
• Decision of the consultant cardiologist to evaluate patient at the ER irrespective of HEART score
• Any significant medical or mental condition, which in the Investigators opinion may interfere with the patients optimal participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Pre-hospital rule-out strategy; Point-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome
No Intervention: Emergency department rule-out strategy; According to standard care, the patients are immediately transported to the emergency department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Study Chair: Niels van Royen, MD PhD Prof, Radboud University Medical Center

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 4, 2022
• Study Completion (Anticipated): May 4, 2023

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Myocardial infarction; Acute Coronary Syndrome; HEART score; Point-of-care troponin
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: NL 66755.091.18; NTR7346 (Registry Identifier: International Clinical Trials Registry Platform); 852001942 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be available to researchers who were granted permission to the data by the principal investigator
• IPD Sharing Time Frame: 1 year after completion
• IPD Sharing Access Criteria: After permission
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No