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

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT05426083
Collaborator
(none)
200
1
34.9
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physiological Assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
Actual Study Start Date :
Aug 4, 2022
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support. [Day 3 of ECMO]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05426083
Other Study ID Numbers:
  • CV-2022-30951
First Posted:
Jun 21, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022