Status:
UNKNOWN
Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Myocardial Infarction Complicated With Cardiogenic Shock
Eligibility:
All Genders
18-88 years
Phase:
PHASE3
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 infarcti...
Eligibility Criteria
Inclusion
- 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
- Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
- Pregnant women
- Absence of maximal support care
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00846222
Start Date
February 1 2009
End Date
July 1 2010
Last Update
February 18 2009
Active Locations (1)
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1
Assaf Harofeh MC
Ẕerifin, Israel, 70300