Strategic target temperature management in myocardial infarction—a feasibility trial

OBJECTIVE: The purpose of this study was to demonstrate the feasibility of a combined cooling strategy started out of hospital as an adjunctive to percutaneous coronary intervention (PCI) in the treatment of ST-elevation acute coronary syndrome (STE-ACS). DESIGN: Non-randomised, single-centre feasibility trial. SETTING: Department of emergency medicine of a tertiary-care facility, Medical University of Vienna, Vienna, Austria. In cooperation with the Municipal ambulance service of the city of Vienna. PATIENTS: Consecutive patients with STE-ACS presenting to the emergency medical service within 6 h after symptom onset. INTERVENTIONS: Cooling was initiated with surface cooling pads in the out-of-hospital setting, followed by the administration of 1000–2000 mL of cold saline at hospital arrival and completed by endovascular cooling in the catheterisation laboratory. MAIN OUTCOME MEASURES: Feasibility of lowering core temperature below 35.0°C prior to immediately performed revascularisation. Safety and tolerability of the cooling procedure. RESULTS: In enrolled 19 patients (one woman, median age 51 years (IQR 45–59)), symptom onset to first medical contact (FMC) was 45 min (IQR 31–85). A core temperature below 35.0°C at reperfusion of the culprit lesion was achieved in 11 patients (78%) within 100 min (IQR 90–111) after FMC without any cooling-related serious adverse event. Temperature could be lowered from baseline 36.4°C (IQR 36.2–36.5°C) to 34.4°C (IQR 34.1–35.0°C) at the time of reperfusion. CONCLUSIONS: With limitations an immediate out-of-hospital therapeutic hypothermia strategy was feasible and safe in patients with STE-ACS undergoing primary PCI. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov/ct2/show/NCT01864343; clinical trials unique identifier: NCT01864343