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Trial record 2 of 61 for:    cardiogenic shock

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Leipzig
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01890317
First received: June 24, 2013
Last updated: June 26, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Leipzig:

Primary Outcome Measures:
  • Cardiac Power Index after 24 hr. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Cardiac Power Index after 24 hours as surrogate endpoint.


Secondary Outcome Measures:
  • 30-days mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change of hemodynamics over the first 48 hr. [ Time Frame: During first 48 hr ] [ Designated as safety issue: No ]
  • Catecholamine dose and duration of catecholamine support [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of ICU-stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • SAPS-II-Score [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    Simplified Acute Physiology Score for the first 4 days

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

Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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: NCT01890317

Contacts
Contact: Holger Thiele, MD +49 341 865 1428 thiel@medizin.uni-leipzig.de
Contact: Georg Fuernau, MD +49 341 865 1428 fuerg@med.uni-leipzig.de

Locations
Germany
Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center Recruiting
Leipzig, Sachsen, Germany, 04289
Contact: Holger Thiele, MD    +493418651428    thielh@medizin.uni-leipzig.de   
Contact: Georg Fuernau, MD    +493418651428    fuerg@med.uni-leipzig.de   
Sponsors and Collaborators
University of Leipzig
Investigators
Study Chair: Holger Thiele, MD University of Leipzig
Principal Investigator: Georg Fuernau, MD University of Leipzig
  More Information

No publications provided

Responsible Party: Holger Thiele, Co-Director Clinic for Internal Medicine/Cardiology, University of Leipzig
ClinicalTrials.gov Identifier: NCT01890317     History of Changes
Other Study ID Numbers: HZLCOOL1
Study First Received: June 24, 2013
Last Updated: June 26, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Leipzig:
Cardiogenic shock
acute myocardial infarction
mild hypothermia

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

ClinicalTrials.gov processed this record on November 27, 2014