Target Temperature Management In Myocardial Infarction - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pre- and perinterventional hypothermia
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.
Intervention: EMCOOLS flex pad; Philips Innercool RTx (Device)
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
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
Secondary Outcomes
- 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))
- Time to revascularisation (first medical contact to balloon time)(Time of reperfusion (in average 120 minutes))
- 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))
Investigators
Dr. Christoph Testori
Department of Emergency Medicine
Medical University of Vienna