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Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT00846222
Recruitment Status : Unknown
Verified February 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:
The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock

Condition or disease Intervention/treatment Phase
Myocardial Infarction Complicated With Cardiogenic Shock Procedure: Hypothermia Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mild theraputic hypothermia Procedure: Hypothermia
Mild therapeutic hypothermia, 33-34 celsius, for 12 hours

Primary Outcome Measures :
  1. Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recent myocardial infarction: 24 hours of start pain
  • Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP < 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
  • Candidate for immediate percutaneous reperfusion
  • Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation

Exclusion Criteria:

  • Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
  • Pregnant women
  • Absence of maximal support care

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): NCT00846222

Assaf Harofeh MC
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Responsible Party: Alex Blatt MD, Assaf Harofeh MC
ClinicalTrials.gov Identifier: NCT00846222     History of Changes
Other Study ID Numbers: 192/08
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Myocardial Infarction
Shock, Cardiogenic
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases