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

Recruiting

• Conditions: Cardiogenic Shock; Acute Coronary Syndrome
• Interventions: Other: Physiological Assessment

• Registration Number: NCT05426083
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2022-08-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physiological Assessment	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States