Target Temperature Management In Myocardial Infarction - A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01864343|
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|ST-elevation Myocardial Infarction||Device: EMCOOLS flex pad; Philips Innercool RTx||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Target Temperature Management In Myocardial Infarction - A Pilot Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||May 2013|
Experimental: 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.
Device: EMCOOLS flex pad; Philips Innercool RTx
Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Innercool RTx)
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864343
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Christoph Testori, MD||Medical University of Vienna, Dept. of Emergency Medicine|