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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426083
• Other study ID #: CV-2022-30951
• Status: Recruiting
• Start date: August 4, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: University of Minnesota
• Contact: Julie Longman
• Phone: 612-625-5949
• Email: longm021[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Other:
• Physiological Assessment
Observational only

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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