[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cyril Camaro\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100612335","pre-hospital-triage-of-patients-at-intermediate-and-high-risk-for-acs-100612335",false,"NCT07252245","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","ARTICA-2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* 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\n* Modified HEAR(T) score ≥ 4\n* The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n* Electrocardiographic ST-segment elevation (STEMI)\n* Patients with confirmed myocardial infarction, PCI or CABG \\\u003C14 days prior to inclu-sion\n* Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.\n* Patients in comatose state, defined as an EMV \\\u003C8\n* Patients with known cognitive impairment\n* Pregnancy or intention to become pregnant during the course of the study\n* Patients presenting with cardiogenic shock, defined as: systolic blood pressure \\\u003C90mmHg and heart rate \\>100 and peripheral oxygen saturation \\\u003C90% (without oxygen administration)\n* Patients presenting with syncope\n* Patients presenting with signs of heart failure\n* Patients presenting with second or third degree atrioventricular block\n* Patients without known supraventricular tachycardia i.e. unknown atrial fibrillation (known atrial fibrillation with adequate rate control can be included)\n* Patients with known end-stage renal disease (dialysis and\u002For GFR \\\u003C 30 ml\u002Fmin)\n* Patients without a pre-hospital 12-lead ECG performed or available\n* Patients suspicious of aortic dissection or pulmonary embolism\n* Communication issues with patient\u002Flanguage barrier\n* Any significant medical or mental condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study","ALL","18 Years",{"count":20,"type":21},1048,"ESTIMATED","INTERVENTIONAL",[24],"NA","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\u002For 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\u002For fast-track diagnosis by CT coronary imaging (intermediate risk) or direct referral to a PCI center for CAG (high risk).\n\nUSUAL CARE\u002FCOMPARISON: Assessment of ACS at the nearest hospital. In case PCI is scheduled: transfer to nearest PCI center.\n\nOUTCOME 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.\n\nSAMPLE SIZE: 1048 patients. COST-EFFECTIVENESS ANALYSIS \u002F 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",[27],"Non ST Segment Elevation Acute Coronary Syndrome",[29,30,31,32,33,34],"HEART score","NSTE-ACS","Pre-hospital triage","high risk ACS","intermediate risk ACS","point-of-care troponin","NOT_YET_RECRUITING","2025-11-18",{"date":38,"type":39},"2025-11-26","ACTUAL",{"date":41,"type":21},"2026-01-01",{"date":43,"type":21},"2030-02-01",{"name":45,"class":46},"Cyril Camaro","OTHER",""]