non-ST elevation acute coronary syndrome (NSTE ACS) myocardial infarction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Adults aged 18 years and older who are deemed mentally competent to make medical decisions • All out-of-hospital patients with chest pain or symptoms suggestive of acute coronary syndrome (ACS) with an indication for transfer to the (cardiac) emergency department to evaluate and rule out ACS • Intermediate to high risk by [History-ECG-Age-Risk factors] HEAR 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
Exclusion criteria: Electrocardiographic ST-segment elevation (STEMI)Patients with confirmed myocardial infarction, PCI or CABG <14 days prior to inclusionPatients 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 <8Patients with known cognitive impairmentPregnancy or intention to become pregnant during the course of the studyPatients 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 syncopePatients presenting with signs of heart failurePatients presenting with second or third degree atrioventricular blockPatients 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 performed or availablePatients suspicious of aortic dissection or pulmonary embolismCommunication issues with patient/language barrierAny significant medical or mental condition, which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| MACE after rule out ACS at 30 days, Quality of life (EQ5D5L) and cost-effectiveness at 12 months. | — |
Countries
Netherlands
Contacts
Radboud Universitair Medisch Centrum