RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-04
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05426083

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-75 years
  2. * SCAI D/E CS requiring VA-ECMO support based on treating team's judgement.
  3. * MAP \>65 mmHg on \<3 vasopressors/inotropes at the time of consent
  4. * Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice
  1. * VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension
  2. * CS due to other (non-ACS) etiologies
  3. * 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
  4. * Profound vasoplegia with MAP \<65 mmHg on 3 vasopressors/inotropes
  5. * Moderate to severe aortic regurgitation (contraindication to VA-ECMO)
  6. * Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter)
  7. * Bleeding complications requiring ongoing transfusions of blood products
  8. * Ischemic lower extremities
  9. * Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation)
  10. * Evidence of sepsis or septic shock
  11. * Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)

Contacts and Locations

Study Contact

Julie Longman
CONTACT
612-625-5949
longm021@umn.edu

Principal Investigator

Demetris Yannopoulous, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Demetris Yannopoulous, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2022-08-04
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2022-08-04
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Acute Coronary Syndrome
  • Cardiogenic Shock