Target Temperature Management In Myocardial Infarction - A Pilot Study

ST-elevation Myocardial Infarction Clinical Trial

Official title:

Target Temperature Management In Myocardial Infarction - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864343
• Other study ID #: STATIM-Pilot
• Secondary ID: MUW_492/2011
• Status: Completed
• Phase: N/A
• First received: May 17, 2013
• Last updated: May 24, 2013
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

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)

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	within 45 days (+/- 15 days)	Yes
Secondary	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)	during active cooling and rewarming (in average the first 4 hours)	No
Secondary	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.	Time of reperfusion (in average 120 minutes)	No