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Completed

NCT Number: NCT01864343

Target Temperature Management In Myocardial Infarction - A Pilot Study

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.

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Key information

Conditions

ST-elevation Myocardial Infarction Anterior Wall Myocardial Infarction Cardiomyopathies Cardiovascular Diseases Heart Diseases Infarction Inferior Wall Myocardial Infarction Ischemia Myocardial Infarction Myocardial Ischemia Myocardial Reperfusion Injury Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMCOOLS flex pad; Philips Innercool RTx

Device

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 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

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 29, 2013
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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