Clinical trial NCT01864343: Target Temperature Management In Myocardial Infarction - A Pilot Study
Official title: Target Temperature Management In Myocardial Infarction - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Keywords: Myocardial Infarction
Myocardial Reperfusion Injury
Reperfusion Injury
Anterior Wall Myocardial Infarction
Inferior Wall Myocardial Infarction
Myocardial Ischemia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)
Secondary outcomes:
measure: Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
timeFrame: within 45 days (+/- 15 days)
measure: Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
timeFrame: during active cooling and rewarming (in average the first 4 hours)
measure: Time to revascularisation (first medical contact to balloon time)
timeFrame: Time of reperfusion (in average 120 minutes)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Dept. of Emergency Medicine
name: Christoph Testori, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Testori C, Sterz F, Delle-Karth G, Malzer R, Holzer M, Stratil P, Stockl M, Weiser C, van Tulder R, Gangl C, Sebald D, Zajicek A, Buchinger A, Lang I. Strategic target temperature management in myocardial infarction--a feasibility trial. Heart. 2013 Nov;99(22):1663-7. doi: 10.1136/heartjnl-2013-304624. Epub 2013 Sep 24.