Trial record 12 of 440 for:    Open Studies | "Myocardial Infarction"

Cooling in Myocardial Infarction (STATIM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical University of Vienna
Sponsor:
Collaborator:
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
Dr. Christoph Testori, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01777750
First received: January 23, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
ST-elevation Myocardial Infarction
Device: EMCOOLS flex pad; Philips Innercool RTx
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strategic Target Temperature Management in Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Infarct size (as percentage of myocardium at risk) assessed by cardiac MRI [ Time Frame: Day 4±2 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Incidence of major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Immune cell activation [ Time Frame: 4±2 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
No Intervention: Standard treatment
Standard 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777750

Contacts
Contact: Christoph Testori, MD +43140400 ext 1964 christoph.testori@meduniwien.ac.at
Contact: Fritz Sterz, MD +43140400 ext 1952 fritz.sterz@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Anton N Laggner, MD    +43140400 ext 1964    anton.laggner@meduniwien.ac.at   
Contact: Fritz Sterz, MD    +43140400 ext 1952    fritz.sterz@meduniwien.ac.at   
Sub-Investigator: Fritz Sterz, MD         
Sub-Investigator: Irene Lang, MD         
Sub-Investigator: Christian Loewe, MD         
Sponsors and Collaborators
Medical University of Vienna
Austrian Science Fund (FWF)
Investigators
Principal Investigator: Christoph Testori, MD Medical University of Vienna, Dept. of Emergency Medicine
  More Information

No publications provided

Responsible Party: Dr. Christoph Testori, Department of Emergency Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01777750     History of Changes
Other Study ID Numbers: KLI209
Study First Received: January 23, 2013
Last Updated: April 28, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Myocardial Infarction
Myocardial Reperfusion Injury
Reperfusion Injury
Anterior Wall Myocardial Infarction
Inferior Wall Myocardial Infarction
Pathologic Processes
Myocardial Ischemia

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014