Cooling in Myocardial Infarction
STATIM
Strategic Target Temperature Management in Myocardial Infarction
1 other identifier
interventional
120
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 if a combined cooling strategy started in the out-of-hospital arena is able to reduce infarct size in acute myocardial infarction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2013
CompletedFirst Posted
Study publicly available on registry
January 29, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedMarch 14, 2019
March 1, 2017
3.4 years
January 23, 2013
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct size (as percentage of myocardium at risk) assessed by cardiac MRI
The primary objective of this study is to demonstrate a reduction in infarct size (as percentage of myocardium at risk) assessed by cardiac MRI at 4±2 days when ST-elevation myocardial infarction is treated with primary coronary intervention (PCI) plus hypothermia compared to PCI alone
Day 4±2
Secondary Outcomes (2)
Incidence of major adverse cardiac events
6 months
Immune cell activation
4±2 days
Study Arms (2)
Pre- and perinterventional hypothermia
ACTIVE COMPARATORCooling 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.
Standard treatment
NO INTERVENTIONStandard treatment
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 Inntercool RTx)
Eligibility Criteria
You may qualify if:
- Age between 18 and 75 years
- Immediate transfer to cath-lab is possible
- Anterior or inferior ST-segment 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/cardiogenic shock
- Tympanic temperature \<35.0°C prior to enrolment
- Thrombolytic therapy
- Previous MI
- Previous PCI or coronary artery bypass graft
- Severe heart failure at presentation (defined as a New York Heart Association (NYHA) functional class III or IV), or Killip classes II through IV
- Clinical signs of active infection
- End-stage kidney disease or hepatic failure
- Recent stroke (within the past six months)
- Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with international normalized ratio \>1.5, severe pulmonary disease
- Pregnancy
- Women of childbearing potential
- Allergy to meperidine, buspirone, magnesium, or polyvinyl chloride
- Use of a monoamine oxidase inhibitor such as selegiline in the previous 14 days
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Viennalead
- Austrian Science Fund (FWF)collaborator
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (2)
Mangold A, Ondracek AS, Hofbauer TM, Scherz T, Artner T, Panagiotides N, Beitzke D, Ruzicka G, Nistler S, Wohlschlager-Krenn E, Winker R, Quehenberger P, Traxler-Weidenauer D, Spannbauer A, Gyongyosi M, Testori C, Lang IM. Culprit site extracellular DNA and microvascular obstruction in ST-elevation myocardial infarction. Cardiovasc Res. 2022 Jun 29;118(8):2006-2017. doi: 10.1093/cvr/cvab217.
PMID: 34173822DERIVEDTestori C, Beitzke D, Mangold A, Sterz F, Loewe C, Weiser C, Scherz T, Herkner H, Lang I. Out-of-hospital initiation of hypothermia in ST-segment elevation myocardial infarction: a randomised trial. Heart. 2019 Apr;105(7):531-537. doi: 10.1136/heartjnl-2018-313705. Epub 2018 Oct 25.
PMID: 30361270DERIVED
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
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Emergency Medicine
Study Record Dates
First Submitted
January 23, 2013
First Posted
January 29, 2013
Study Start
February 1, 2013
Primary Completion
July 1, 2016
Study Completion
January 1, 2019
Last Updated
March 14, 2019
Record last verified: 2017-03