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

Radboud University Medical Center

Status: Active, not recruiting

Conditions: Acute Coronary Syndrome

Treatments: Diagnostic Test: Pre-hospital rule-out strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05466591

NTR7346 (Registry Identifier)

NL 66755.091.18

852001942 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 866 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

866 participants in 2 patient groups

Pre-hospital rule-out strategy

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Pre-hospital rule-out strategy

Emergency department rule-out strategy

No Intervention group

Description:

According to standard care, the patients are immediately transported to the emergency department.