Clinical trial NCT05426083: Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
Official title: Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Cardiogenic Shock
Keywords: Acute Coronary Syndrome
Cardiogenic Shock
Left ventricle
VA-ECMO
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-75 years of age who were cannulated for VA-ECMO because of ischemic cardiogenic shock (SCAI shock categories D and E)44 per standard clinical practice. Acute coronary syndrome will be verified by the presence of an acute coronary cause identified on invasive coronary angiography.

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 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 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)

Primary outcomes:
measure: Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.
timeFrame: Day 3 of ECMO
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Demetris Yannopoulous, MD
role: PRINCIPAL_INVESTIGATOR
References: