Status:
RECRUITING
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
Lead Sponsor:
University of Minnesota
Conditions:
Acute Coronary Syndrome
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Brief Summary
A Clinical Events Committee (CEC) will include Cardiac Surgery Professor and chief of cardiac surgery Rose Kelly MD, Professor of Medicine Ganesh Raveendran MD at the University of Minnesota who is th...
Eligibility Criteria
Inclusion
- Age 18-75 years
- SCAI D/E CS requiring VA-ECMO support based on treating team's judgement.
- MAP \>65 mmHg on \<3 vasopressors/inotropes at the time of consent
- Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice
Exclusion
- VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension
- CS due to other (non-ACS) etiologies
- Known patient with severe left ventricular dysfunction and stage IV NYHA heart failure being evaluated for or with a history of LVAD and transplantation prior to commencement of VA-ECMO
- Profound vasoplegia with MAP \<65 mmHg on 3 vasopressors/inotropes
- Moderate to severe aortic regurgitation (contraindication to VA-ECMO)
- Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter)
- Bleeding complications requiring ongoing transfusions of blood products
- Ischemic lower extremities
- Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation)
- Evidence of sepsis or septic shock
- Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)
Key Trial Info
Start Date :
August 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05426083
Start Date
August 4 2022
End Date
December 31 2026
Last Update
August 3 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455