Cooling in Myocardial Infarction
This trial is active, not recruiting.
|Condition||st-elevation myocardial infarction|
|Treatment||emcools flex pad; philips innercool rtx|
|Sponsor||Medical University of Vienna|
|Collaborator||Austrian Science Fund (FWF)|
|Start date||February 2013|
|End date||July 2016|
|Trial size||120 participants|
|Trial identifier||NCT01777750, KLI209|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Infarct size (as percentage of myocardium at risk) assessed by cardiac MRI
time frame: Day 4±2
Incidence of major adverse cardiac events
time frame: 6 months
Immune cell activation
time frame: 4±2 days
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Age between 18 and 75 years - Immediate transfer to cath-lab is possible - Anterior or inferior ST-segment 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/cardiogenic shock - Tympanic temperature <35.0°C prior to enrolment - Thrombolytic therapy - Previous MI - Previous PCI or coronary artery bypass graft - Severe heart failure at presentation (defined as a New York Heart Association (NYHA) functional class III or IV), or Killip classes II through IV - Clinical signs of active infection - End-stage kidney disease or hepatic failure - Recent stroke (within the past six months) - Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with international normalized ratio >1.5, severe pulmonary disease - Pregnancy - Women of childbearing potential - Allergy to meperidine, buspirone, magnesium, or polyvinyl chloride - Use of a monoamine oxidase inhibitor such as selegiline in the previous 14 days - absolute contraindications against MRI (PM, ICD, ferromagnetic implants)
|Official title||Strategic Target Temperature Management in Myocardial Infarction|
|Principal investigator||Christoph Testori, MD|
|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.|
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