Myocardial Infarction Complicated With Cardiogenic Shock
Conditions
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
Interventions
PROCEDUREHypothermia
Mild therapeutic hypothermia, 33-34 celsius, for 12 hours
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction. | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment | 30 days |
Countries
Israel
Outcome results
None listed