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

NCT ID: NCT05426083

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2026-12-31

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.

Conditions

Acute Coronary Syndrome; Cardiogenic Shock

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Physiological Assessment

Prospective physiological assessment of LV work and oxygen consumption in patients with SCAI D/E cardiogenic shock due to acute coronary syndrome treated with peripheral VA-ECMO support.

Physiological Assessment

Intervention Type: OTHER

Observational only

Interventions

Physiological Assessment

Observational only

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Demetris Yannopoulous, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie Longman

Role: CONTACT

longm021@umn.edu

612-625-5949

Facility Contacts

Julie Longman

Role: primary

longm021@umn.edu

612-625-5949

Other Identifiers

CV-2022-30951

Identifier Type: -

Identifier Source: org_study_id