Not Yet RecruitingNot Applicable

Pre Hospital Triage of Patients at Intermediate and High Risk for ACS

Netherlands1,048 participantsStarted 2026-01-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Electrocardiographic ST-segment elevation (STEMI) * Patients with confirmed myocardial infarction, PCI or CABG \<14 days prior to inclu-sion * 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 EMV \<8 * Patients with known cognitive impairment * Pregnancy or intention to become pregnant during the course of the study * 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 syncope * Patients presenting with signs of heart failure * 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 with known end-stage renal disease (dialysis and/or GFR \< 30 ml/min) * Patients without a pre-hospital 12-lead ECG perf…

What they're measuring

Non-inferiority for MACE

Timeframe: from enrollment to end of treatment at 30 days and 12 months

Healthcare costs

Timeframe: from enrollment to end of treatment at 30 days and 12 months

Trial details

NCT IDNCT07252245

SponsorCyril Camaro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

Cyril Camaro, MD

+31243616785 articastudie.cardio@radboudumc.nl