Target Temperature Management In Myocardial Infarction - A Pilot Study

Medical University of Vienna

Status: Completed

Conditions: ST-elevation Myocardial Infarction

Treatments: Device: EMCOOLS flex pad; Philips Innercool RTx

Study type: Interventional

Funder types: Other

Identifiers

NCT01864343

STATIM-Pilot

MUW_492/2011

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Pre- and perinterventional hypothermia

Experimental group

Description:

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.

Treatment:

Device: EMCOOLS flex pad; Philips Innercool RTx