Status:
RECRUITING
Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction
Lead Sponsor:
Efferon JSC
Conditions:
Myocardial Infarction
Cardiogenic Shock
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Cardiogenic shock is the most severe manifestation of acute heart failure and remains the leading cause of death in patients hospitalised with acute myocardial infarction. Cardiogenic shock is a well...
Detailed Description
Cardiogenic shock (CS) is a state of acute critical tissue hypoperfusion caused by impaired myocardial contractility. It is one of the most serious complications of acute coronary syndrome (ACS), part...
Eligibility Criteria
Inclusion
- Not more than 4 hours after diagnosis Cardiogenic shock complicating acute myocardial infarction
- Stages B - C of cardiogenic shock according to SCAI
- Patient condition allows treatment with Efferon® CT device for at least 4 hours
- SOFA score 12 or less
Exclusion
- Broken-heart syndrome (takotsubo cardiomyopathy)
- Postcardiotomy cardiogenic shock
- Acute myocardial infarction within the last 4 weeks
- Myocarditis
- Cardiac trauma
- Charlson comorbidity index greater than 9 points
- Chronic kidney disease, stage 5 D (requiring continuous hemodialysis)
- Acute pulmonary embolism
- Acute cerebral circulatory collapse
- Transfusion reaction
- Patients on immunosuppressive therapy for cancer and autoimmune diseases
- Pregnancy
- Any other clinical condition of the patient that in the opinion of the investigator precludes inclusion in this study
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06955936
Start Date
April 29 2025
End Date
July 31 2027
Last Update
June 5 2025
Active Locations (1)
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1
Tomsk NRMC Cardiology Research Institute
Tomsk, Russia, 634012