Target Temperature Management In Myocardial Infarction - A Pilot Study

NCT ID: NCT01864343

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-05-31

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.

Conditions

ST-elevation Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EMCOOLS flex pad; Philips Innercool RTx

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Christoph Testori

Department of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Testori, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Dept. of Emergency Medicine

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 24064228 (View on PubMed)

Other Identifiers

MUW_492/2011

Identifier Type: -

Identifier Source: secondary_id

STATIM-Pilot

Identifier Type: -

Identifier Source: org_study_id