Target Temperature Management In Myocardial Infarction - A Pilot Study
2 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedMay 29, 2013
May 1, 2013
1.6 years
May 17, 2013
May 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Blood temperature will be recorded at the time of first wire-crossed lesion of the infarct related coronary stenosis
Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)
Secondary Outcomes (3)
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)
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)
Study Arms (1)
Pre- and perinterventional hypothermia
EXPERIMENTALCooling 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, Vienna, 1090, Austria
Related Publications (1)
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.
PMID: 24064228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Testori, MD
Medical University of Vienna, Dept. of Emergency Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Emergency Medicine
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 29, 2013
Study Start
September 1, 2011
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
May 29, 2013
Record last verified: 2013-05