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Target Temperature Management In Myocardial Infarction - A Pilot Study

Primary Purpose

ST-elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
EMCOOLS flex pad; Philips Innercool RTx
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring Myocardial Infarction, Myocardial Reperfusion Injury, Reperfusion Injury, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction, Myocardial Ischemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre- and perinterventional hypothermia

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
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
Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
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)
Time to revascularisation (first medical contact to balloon time)
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.

Full Information

First Posted
May 17, 2013
Last Updated
May 24, 2013
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01864343
Brief Title
Target Temperature Management In Myocardial Infarction - A Pilot Study
Official Title
Target Temperature Management In Myocardial Infarction - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction
Keywords
Myocardial Infarction, Myocardial Reperfusion Injury, Reperfusion Injury, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction, Myocardial Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre- and perinterventional hypothermia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EMCOOLS flex pad; Philips Innercool RTx
Intervention Description
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 Measure Information:
Title
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
Description
Blood temperature will be recorded at the time of first wire-crossed lesion of the infarct related coronary stenosis
Time Frame
Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)
Secondary Outcome Measure Information:
Title
Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
Description
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
Time Frame
within 45 days (+/- 15 days)
Title
Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
Description
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)
Time Frame
during active cooling and rewarming (in average the first 4 hours)
Title
Time to revascularisation (first medical contact to balloon time)
Description
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.
Time Frame
Time of reperfusion (in average 120 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Testori, MD
Organizational Affiliation
Medical University of Vienna, Dept. of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
24064228
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.
Results Reference
derived

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Target Temperature Management In Myocardial Infarction - A Pilot Study

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