Target Temperature Management In Myocardial Infarction - A Pilot Study

Medical University of Vienna19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ST-elevation Myocardial Infarction

Interventions

EMCOOLS flex pad; Philips Innercool RTxDEVICE

Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Innercool RTx)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 75 years * Immediately transfer to cath-lab is possible * Anterior or inferior ST-Elevation myocardial infarction * ST-Segment elevation of \>0.2mV in 2 or more anatomically contiguous leads * Duration of symptoms \<6 hours 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

Locations (1)

Medical University of Vienna

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

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

Blood temperature will be recorded at the time of first wire-crossed lesion of the infarct related coronary stenosis

Time frame: Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)

Secondary Outcomes

Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction

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

Time frame: within 45 days (+/- 15 days)

Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction

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 frame: during active cooling and rewarming (in average the first 4 hours)

Time to revascularisation (first medical contact to balloon time)

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.

Time frame: Time of reperfusion (in average 120 minutes)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.