Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05426083

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Coronary Syndrome Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Julie Longman

CONTACT

[email protected]

612-625-5949

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physiological Assessment

Other

Observational only

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Longman

CONTACT

[email protected]

612-625-5949

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2022
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.