Clinical Trial: Target Temperature Management In Myocardial Infarction - A Pilot Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Target Temperature Management In Myocardial Infarction - A Pilot Study

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.


Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: 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 Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction [ Time Frame: 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
  • Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction [ Time Frame: 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 Frame: 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.


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: May 17, 2013
Date Started: September 2011
Date Completion:
Last Updated: May 24, 2013
Last Verified: May 2013