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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
Sponsor:
Information provided by (Responsible Party):
Dr. Christoph Testori, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
ST-elevation Myocardial Infarction Device: EMCOOLS flex pad; Philips Innercool RTx Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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)




Primary Outcome Measures :
  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 [ 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Christoph Testori, MD Medical University of Vienna, Dept. of Emergency Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Christoph Testori, Department of Emergency Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01864343     History of Changes
Other Study ID Numbers: STATIM-Pilot
MUW_492/2011
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Keywords provided by Dr. Christoph Testori, Medical University of Vienna:
Myocardial Infarction
Myocardial Reperfusion Injury
Reperfusion Injury
Anterior Wall Myocardial Infarction
Inferior Wall Myocardial Infarction
Myocardial Ischemia
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases