RecruitingNCT05426083

Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock

Sponsor

University of Minnesota

Enrollment

200 participants

Start Date

Aug 4, 2022

Study Type

OBSERVATIONAL

Conditions

Acute Coronary Syndrome Cardiogenic Shock

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 the direction of Interventional Cardiology and Professor of Medicine at the University of Minnesota David Benditt. They will review and adjudicate serious and unexpected adverse events independently from the PI and co investigators.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria11

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)