NCT07252245Recruiting
Pre Hospital Triage of Patients at Intermediate and High Risk for ACS
Pre Hospital Triage of Patients at Intermediate and High Risk for ACS: ARTICA-2 Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
RESEARCH QUESTION: Is a treatment strategy that includes direct referral to a PCI center for intermediate to high-risk patients with non-ST elevation acute coronary syndrome (NSTE-ACS), both cost-effective and non-inferior for major adverse cardiac events (MACE)? HYPOTHESIS: Prehospital triage with the modified \[History-ECG-Age-Risk factors\] (HEAR) score and a high sensitivity (hs) point-of-care troponin (POCT) leads to a faster diagnosis of ACS, faster time to coronary angiography (CAG) and/or treatment with PCI, shorter length of stay, quicker availability of ambulances and more satisfaction and quality of life of patients. STUDY DESIGN: Randomized clinical trial. STUDY POPULATION: Patients ≥18 years with an intermediate to high risk for NSTE -ACS (defined as a modified HEAR score ≥ 4) INTERVENTION: applying modified HEAR score and hs POCT to identify patients for direct rule out (very low risk), transfer to the nearest hospital for rapid rule-out and/or fast-track diagnosis by CT coronary imaging (intermediate risk) or direct referral to a PCI center for CAG (high risk). USUAL CARE/COMPARISON: Assessment of ACS at the nearest hospital. In case PCI is scheduled: transfer to nearest PCI center. OUTCOME MEASURES: primary endpoints: healthcare costs and non-inferiority for MACE (all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG) at 30 days. Secondary: MACE after rule out ACS at 30 days, Quality of life (EQ5D5L) and cost-effectiveness at 12 months. SAMPLE SIZE: 1048 patients. COST-EFFECTIVENESS ANALYSIS / BIA: It is expected that the intervention group will reduce healthcare costs and potentially improve health-related quality of life in this target population. Cost-effectiveness will be expressed as cost per QALY gained. We assume a large potential saving more than € 37 million if 100% implemented. TIME SCHEDULE: 48 months; 36 month inclusion, follow-up 12 months
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1048 (estimated)
- First submitted
- 30 Sept 2025
- Start date
- 4 Sept 2026
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Cyril Camaro
- Diseases
- Coronary artery disease
- NCT number
- NCT07252245
What you commit to
- Study type: Interventional
- Planned participants: 1048
- From 4 Sept 2026 to the primary completion date, 1 Jan 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with confirmed myocardial infarction, PCI or CABG \<14 days prior to inclu-sion
Other illness
- 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 with known cognitive impairment
- Patients presenting with cardiogenic shock, defined as: systolic blood pressure \<90mmHg and heart rate \>100 and peripheral oxygen saturation \<90% (without oxygen administration)
- Patients presenting with signs of heart failure
- Any significant medical or mental condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study
Lab values
- Patients with known end-stage renal disease (dialysis and/or GFR \< 30 ml/min)
Other
- Electrocardiographic ST-segment elevation (STEMI)
- Patients in comatose state, defined as an EMV \<8
- Pregnancy
- Patients presenting with syncope
- Patients presenting with second or third degree atrioventricular block
- Patients without known supraventricular tachycardia i.e. unknown atrial fibrillation (known atrial fibrillation with adequate rate control can be included)
- Patients without a pre-hospital 12-lead ECG performed or available
- Patients suspicious of aortic dissection or pulmonary embolism
- Communication issues with patient/language barrier
Who the study is looking for
- Age ≥ 18 years
- All out-of-hospital patients with chest pain or symptoms suggestive of ACS with an indication for transfer to the (cardiac) emergency department to evaluate and rule out ACS
- Modified HEAR(T) score ≥ 4
- The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RAV Brabant midden-west-noord: post Haps Coordinator of this site? Confirm its status | Haps | Netherlands | Recruiting |
| Veiligheidsregio Gelderland-Zuid Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Radboudumc Nijmegen, The Netherlands Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.