Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physiological Assessment.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome, Cardiogenic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Physiological Assessment
Observational only
Primary outcome measures
- Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support. [Time frame: Day 3 of ECMO]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT05426083 · CV-2022-30951