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Recruiting NCT06955936

NCT06955936 Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

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Clinical Trial Summary
NCT ID NCT06955936
Status Recruiting
Phase
Sponsor Efferon JSC
Condition Myocardial Infarction
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2025-04-29
Primary Completion 2027-04-29

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
Efferon CT

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2025-04-29 with a primary completion date of 2027-04-29.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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-known and potent trigger of the immune response, ischemia/reperfusion organ damage, hemolysis and release of free hemoglobin. The activation of immune cells leads to the release of cytokines and inflammatory mediators such as IL-6, IL-8, activated complement and others. As a result of myocardial ischaemia and reperfusion injury, a multiorgan dysfunction syndrome may develop. The Efferon CT hemoadsorption device effectively removes cytokines and other pro-inflammatory molecules (≤55 kDa). This study evaluates whether this blood-filtering therapy can prevent organ failure in acute myocardial infarction patients with cardiogenic shock by eliminating inflammation-inducing mediators.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

Contact & Investigator

Central Contact

Alexandr Shelehov-Kravchenko, PhD, MD

✉ alexandr.shelehov@gmail.com

📞 +79636564765

Principal Investigator

Vyacheslav Ryabov, PhD, MD

PRINCIPAL INVESTIGATOR

Tomsk NRMC Cardiology Research Institute

Frequently Asked Questions

Who can join the NCT06955936 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06955936 currently recruiting?

Yes, NCT06955936 is actively recruiting participants. Contact the research team at alexandr.shelehov@gmail.com for enrollment information.

Where is the NCT06955936 trial being conducted?

This trial is being conducted at Tomsk, Russia.

Who is sponsoring the NCT06955936 clinical trial?

NCT06955936 is sponsored by Efferon JSC. The principal investigator is Vyacheslav Ryabov, PhD, MD at Tomsk NRMC Cardiology Research Institute. The trial plans to enroll 60 participants.

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