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

July 31, 2025 updated by: University of Minnesota
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.
Day 3 of ECMO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Demetris Yannopoulous, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV-2022-30951

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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