Cooling in Myocardial Infarction (STATIM)

March 13, 2019 updated by: Dr. Christoph Testori, Medical University of Vienna

Strategic Target Temperature Management in Myocardial Infarction

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 if a combined cooling strategy started in the out-of-hospital arena is able to reduce infarct size in acute myocardial infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Contemporary therapy in patients with an on-going ST-elevation myocardial infarction (STEMI) is to reperfuse the ischemic myocardium as soon as possible to reduce infarct size and associated complications. A recent pilot-study showed a significant reduction in infarct size by the induction of pre-reperfusion hypothermia.

Objectives: To demonstrate a reduction in infarct size/myocardium at risk (measured by magnet resonance imaging) in patients with ST-Elevation myocardial infarction by strategic temperature management with the use of external cooling pads in the out-of-hospital setting and the continuation with cold saline and central venous catheter cooling in hospital. In a parallel translational study, the molecular effects of rapid and early cooling on inflammatory processes at the culprit lesion site will be defined.

Methodology: Randomized, prospective, controlled trial Number of subjects: 120 patients (60 per group) Investigational medical device: EMCOOLS flex pad is an external cooling pad, that consists of multiple cooling cells filled with a patented cooling gel. EMCOOLS flex pad will be used in the out-of-hospital setting to initiate cooling. The Philips RTx Endovascular System™ is an endovascular thermal control system that circulates cooled saline through an indwelling central venous catheter in a closed-loop manner. It will be used in combination with 1-2 litres of intravenous cold saline to induce hypothermia below 35 degrees Celsius.

Duration: One hour after successful revascularization the cooling procedure will be stopped, subjects will be covered with a blanket and are allowed to passively re-warm. Clinical follow-up for 180 days.

Primary endpoint: Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI at 4±2 days. Influence of target temperature management on coronary macrophages and monocytes as well as impact on plasma levels of immune cell chemotaxis and activation.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 75 years
  • Immediate transfer to cath-lab is possible
  • Anterior or inferior ST-segment 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/cardiogenic shock
  • Tympanic temperature <35.0°C prior to enrolment
  • Thrombolytic therapy
  • Previous MI
  • Previous PCI or coronary artery bypass graft
  • Severe heart failure at presentation (defined as a New York Heart Association (NYHA) functional class III or IV), or Killip classes II through IV
  • Clinical signs of active infection
  • End-stage kidney disease or hepatic failure
  • Recent stroke (within the past six months)
  • Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with international normalized ratio >1.5, severe pulmonary disease
  • Pregnancy
  • Women of childbearing potential
  • Allergy to meperidine, buspirone, magnesium, or polyvinyl chloride
  • Use of a monoamine oxidase inhibitor such as selegiline in the previous 14 days
  • absolute contraindications against MRI (PM, ICD, ferromagnetic implants)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard treatment
ACTIVE_COMPARATOR: 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 Inntercool RTx)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size (as percentage of myocardium at risk) assessed by cardiac MRI
Time Frame: Day 4±2
The primary objective of this study is to demonstrate a reduction in infarct size (as percentage of myocardium at risk) assessed by cardiac MRI at 4±2 days when ST-elevation myocardial infarction is treated with primary coronary intervention (PCI) plus hypothermia compared to PCI alone
Day 4±2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major adverse cardiac events
Time Frame: 6 months
The effect of the hypothermia protocol on the incidence of the composite of death, heart failure, recurrent MI, malignant arrhythmias (i.e. ventricular fibrillation, sustained ventricular tachycardia) emergent stent revascularisation or any hospitalisation at 45±15 days and 6 months.
6 months
Immune cell activation
Time Frame: 4±2 days
Impact of hypothermia on the number, the activation state, the adhesion and transmigratory capacity of coronary and systemic neutrophils and monocytes as well as impact of hypothermia on coronary and systemic plasma levels of soluble proteins related to innate immune cell chemotaxis and activation.
4±2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Austrian Science Fund (FWF)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

January 1, 2019

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (ESTIMATE)

January 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLI209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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