Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
Phase 3
- Conditions
- Myocardial Infarction Complicated With Cardiogenic Shock
- Interventions
- Procedure: Hypothermia
- Registration Number
- NCT00846222
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mild theraputic hypothermia Hypothermia -
- Primary Outcome Measures
Name Time Method Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction. 30 days
- Secondary Outcome Measures
Name Time Method Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment 30 days
Trial Locations
- Locations (1)
Assaf Harofeh MC
🇮🇱Zerifin, Israel