Cooling in Myocardial Infarction
Condition: ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

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 if a combined cooling strategy started in the
      out-of-hospital arena is able to reduce infarct size in acute myocardial infarction.
    

Detailed description: 
      Background: Contemporary therapy in patients with an on-going ST-elevation myocardial
      infarction (STEMI) is to reperfuse the ischemic myocardium as soon as possible to reduce
      infarct size and associated complications. A recent pilot-study showed a significant
      reduction in infarct size by the induction of pre-reperfusion hypothermia.

      Objectives: To demonstrate a reduction in infarct size/myocardium at risk (measured by magnet
      resonance imaging) in patients with ST-Elevation myocardial infarction by strategic
      temperature management with the use of external cooling pads in the out-of-hospital setting
      and the continuation with cold saline and central venous catheter cooling in hospital. In a
      parallel translational study, the molecular effects of rapid and early cooling on
      inflammatory processes at the culprit lesion site will be defined.

      Methodology: Randomized, prospective, controlled trial Number of subjects: 120 patients (60
      per group) Investigational medical device: EMCOOLS flex pad is an external cooling pad, that
      consists of multiple cooling cells filled with a patented cooling gel. EMCOOLS flex pad will
      be used in the out-of-hospital setting to initiate cooling. The Philips RTx Endovascular
      System™ is an endovascular thermal control system that circulates cooled saline through an
      indwelling central venous catheter in a closed-loop manner. It will be used in combination
      with 1-2 litres of intravenous cold saline to induce hypothermia below 35 degrees Celsius.

      Duration: One hour after successful revascularization the cooling procedure will be stopped,
      subjects will be covered with a blanket and are allowed to passively re-warm. Clinical
      follow-up for 180 days.

      Primary endpoint: Myocardial infarct size (as a percentage of myocardium at risk) assessed by
      cardiac MRI at 4±2 days. Influence of target temperature management on coronary macrophages
      and monocytes as well as impact on plasma levels of immune cell chemotaxis and activation.
    

Intervention name(s): EMCOOLS flex pad; Philips Innercool RTx
Intervention type(s): Device
Intervention description(s): Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Inntercool RTx)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial Infarction; Myocardial Reperfusion Injury; Reperfusion Injury; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction; Pathologic Processes; Myocardial Ischemia