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

NCT05426083 | Recruiting DMC

• 1 other identifier: CV-2022-30951
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Coronary Syndrome; Cardiogenic Shock; Left ventricle; VA-ECMO

Outcome Measures

Primary Outcomes (1)

• Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.

  Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.

  Day 3 of ECMO

Study Arms (1)

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.

Other: Physiological Assessment

Interventions

Physiological Assessment OTHER

Observational only

Physiological Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Demetris Yannopoulous, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Longman

CONTACT

612-625-5949; longm021@umn.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: August 4, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (1)