Target Temperature Management In Myocardial Infarction - A Pilot Study

Not Applicable

Completed

Brief Summary: The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling to temperatures below 35°C before revascularisation can additionally reduce infarct size and therefore improves outcome in these patients.

The purpose of the study is to determine the feasibility and safety of a combined cooling strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in patients with acute st-elevation myocardial infarction.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Participation in another study
Patients presenting with cardiac arrest
Tympanic temperature of <35.0°C prior enrolment
Thrombolysis therapy
Previous myocardial infarction in medical history
Previous percutaneous coronary intervention or coronary artery bypass graft
Severe heart failure (defined as a New York Heart Association (NYHA) score of III or IV), Killip class II through IV at presentation
Clinical signs of infection
End-stage kidney disease or hepatic failure
Recent stroke (within the last six month)
Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with international normalized radio >1.5, severe pulmonary disease
Pregnancy. Women of childbearing potential are excluded
Allergy to meperidine, buspirone, magnesium, or polyvinyl chloride
Use of a monoamine oxidase inhibitor such as selegiline in the previous 14 days

Arm && Interventions

Group	Intervention	Description
Pre- and perinterventional hypothermia	EMCOOLS flex pad; Philips Innercool RTx	Cooling will be initiated by the application of cooling pads in the out-of-hospital setting followed by an infusion of 1000-2000ml of cold saline. In the cath lab a endovascular cooling catheter will be placed into the inferior vena cava via a femoral vein to achieve a core temperature of \<35°C prior to revascularization.

Primary Outcome Measures

Name	Time	Method
Feasibility of a combined cooling strategy for achieving a core temperature of <35.0°C at the time of reperfusion of the infarct related artery	Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)	Blood temperature will be recorded at the time of first wire-crossed lesion of the infarct related coronary stenosis

Secondary Outcome Measures

Name	Time	Method
Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction	during active cooling and rewarming (in average the first 4 hours)	Patients are monitored for incidence of shivering using a 4-point scale: 0, no shivering evident; 1, isolated facial or masticatory fasciculation; 2, peripheral shivering; 3, uncontrolled rigor during the cooling procedure (in average the first 4 hours)
Time to revascularisation (first medical contact to balloon time)	Time of reperfusion (in average 120 minutes)	The time to reperfusion of the infarct related artery is crucial in acute ST-elevation myocardial infarction. To evaluate if the cooling procedure has a substantial influence on this time frame we measure the time from first medical contact to reperfusion.
Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction	within 45 days (+/- 15 days)	Incidence of major adverse cardiac events as defined as: death, heart failure, pulmonary edema, recurrent MI, malignant arrhythmias (i.e. ventricular fibrillation, sustained ventricular tachycardia) emergent stent revascularisation, any hospitalisation, major/minor bleeding (according to TIMI-bleeding score), infection (clinical relevant infection with the need of systemic antimicrobiotic therapy) within a period of 45±15 days

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