NCT05426083 Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
| NCT ID | NCT05426083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Acute Coronary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-08-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-08-04 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Demetris Yannopoulous, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05426083 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05426083 currently recruiting?
Yes, NCT05426083 is actively recruiting participants. Contact the research team at longm021@umn.edu for enrollment information.
Where is the NCT05426083 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05426083 clinical trial?
NCT05426083 is sponsored by University of Minnesota. The principal investigator is Demetris Yannopoulous, MD at University of Minnesota. The trial plans to enroll 200 participants.