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Clinical Trial
Strategic target temperature management in myocardial infarction--a feasibility trial.
- Christoph Testori, Fritz Sterz, Georg Delle-Karth, Reinhard Malzer, Michael Holzer, Peter Stratil, Mathias Stöckl, Christoph Weiser, Raphael van Tulder, Clemens Gangl, Dieter Sebald, Andreas Zajicek, Angelika Buchinger, and Irene Lang.
- Department of Emergency Medicine, Medical University of Vienna, , Vienna, Austria.
- Heart. 2013 Nov 1;99(22):1663-7.
ObjectiveThe 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).DesignNon-randomised, single-centre feasibility trial.SettingDepartment 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.PatientsConsecutive patients with STE-ACS presenting to the emergency medical service within 6 h after symptom onset.InterventionsCooling 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 MeasuresFeasibility of lowering core temperature below 35.0°C prior to immediately performed revascularisation. Safety and tolerability of the cooling procedure.ResultsIn 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.ConclusionsWith limitations an immediate out-of-hospital therapeutic hypothermia strategy was feasible and safe in patients with STE-ACS undergoing primary PCI.Clinical Trial Registrationhttp://www.clinicaltrials.gov/ct2/show/NCT01864343; clinical trials unique identifier: NCT01864343.
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