Effects of VA-ECMO on heart function during cardiogenic shock
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
This study is testing how veno-arterial ECMO support affects heart function in adults aged 18 to 75 who are experiencing cardiogenic shock from a heart condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05426083 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the physiological effects of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support in patients experiencing cardiogenic shock due to acute coronary syndrome. A Clinical Events Committee, consisting of leading cardiac surgery and interventional cardiology experts from the University of Minnesota, will independently review and adjudicate any serious and unexpected adverse events. The study will focus on patients aged 18-75 who meet specific criteria for VA-ECMO support, allowing for a detailed understanding of the treatment's impact on left ventricular function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with cardiogenic shock due to acute coronary syndrome requiring VA-ECMO support.
Not a fit: Patients with cardiogenic shock from non-ACS causes or those with severe left ventricular dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of cardiogenic shock and improve patient outcomes through better understanding of VA-ECMO effects.
How similar studies have performed: While there have been studies on VA-ECMO, this specific observational approach focusing on physiological effects in acute coronary syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Demetris Yannopoulous, MD — University of Minnesota
- Study coordinator: Julie Longman
- Email: longm021@umn.edu
- Phone: 612-625-5949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.