ARTICA: Pre-hospital Rule-out of Acute Coronary Syndrome

Sponsor

Radboud University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05466591

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

866

Enrollment

Location

Arms

50.1

Anticipated Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Diagnostic Test: Pre-hospital rule-out strategy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

866 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The clinical events are blindly adjudicated by an independent Clinical Events Committee

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Jun 4, 2022

Anticipated Study Completion Date :

May 4, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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) [6 months]
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Safety (all cause death, acute coronary syndrome, unplanned revascularisation) [12 months]
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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