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Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction (SHOCK-COOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01890317
First Posted: July 1, 2013
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Holger Thiele, Heartcenter Leipzig GmbH
  Purpose
Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.

Condition Intervention
Acute; Myocardial Infarction, Complications Cardiogenic Shock Procedure: Mild hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Holger Thiele, Heartcenter Leipzig GmbH:

Primary Outcome Measures:
  • Cardiac Power Index after 24 hr. [ Time Frame: 24 hours ]
    Cardiac Power Index after 24 hours as surrogate endpoint.


Secondary Outcome Measures:
  • 30-days mortality [ Time Frame: 30 days ]
  • Change of hemodynamics over the first 48 hr. [ Time Frame: During first 48 hr ]
  • Catecholamine dose and duration of catecholamine support [ Time Frame: 30 days ]
  • Length of ICU-stay [ Time Frame: 30 days ]
  • Length of mechanical ventilation [ Time Frame: 30 days ]
  • SAPS-II-Score [ Time Frame: 96 hours ]
    Simplified Acute Physiology Score for the first 4 days

  • Severe and moderate bleeding complications (GUSTO-definition) [ Time Frame: 30 days ]
  • Sepsis [ Time Frame: 30 days ]
  • Pneumonia [ Time Frame: 30 days ]
  • Stroke [ Time Frame: 30 days ]

Estimated Enrollment: 40
Study Start Date: August 2012
Study Completion Date: March 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild hypothermia
Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy
Procedure: Mild hypothermia
Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
No Intervention: Control
Percutaneous coronary intervention and optimal medical therapy according to current guidelines

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute myocardial infarction complicated by cardiongenic shock
  • Patients on mechanical ventilation at time of randomization

Exclusion Criteria:

  • Out of hospital resuscitation with indication for mild hypothermia
  • mechanical complications after acute myocardial infarction
  • duration of cardiogenic shock > 12 hours
  • age > 90 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890317


Locations
Germany
Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center
Leipzig, Sachsen, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Study Chair: Holger Thiele, MD Heartcenter Leipzig GmbH
Principal Investigator: Georg Fuernau, MD Heartcenter Leipzig GmbH
  More Information

Responsible Party: Holger Thiele, Co-Director Clinic for Internal Medicine/Cardiology, Heartcenter Leipzig GmbH
ClinicalTrials.gov Identifier: NCT01890317     History of Changes
Other Study ID Numbers: HZLCOOL1
First Submitted: June 24, 2013
First Posted: July 1, 2013
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Holger Thiele, Heartcenter Leipzig GmbH:
Cardiogenic shock
acute myocardial infarction
mild hypothermia

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Shock
Hypothermia
Shock, Cardiogenic
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Body Temperature Changes
Signs and Symptoms