Clinical trial NCT05466591: Pre-hospital Rule-out of Acute Coronary Syndrome
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Point-of-care troponin
HEART score
Acute Coronary Syndrome
Myocardial infarction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-07-20
Enrollment: 866
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)
timeFrame: 30 days
Secondary outcomes:
measure: Safety: all cause death, acute coronary syndrome, unplanned revascularisation
timeFrame: 30 days
measure: Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)
timeFrame: 30 days
measure: Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
timeFrame: 6 months
measure: Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
timeFrame: 12 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
Study officials:
affiliation: Radboud University Medical Center
name: Niels van Royen, MD PhD Prof
role: STUDY_CHAIR
References: