Acute Coronary SyndromeNCT05426083
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
An observational study of Acute Coronary Syndrome and Cardiogenic Shock, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Cardiogenic Shock
- What is being tested?
- Physiological Assessment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2022to 26 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18-75 years of age who were cannulated for VA-ECMO because of ischemic cardiogenic shock (SCAI shock categories D and E)44 per standard clinical practice. Acute coronary syndrome will be verified by the presence of an acute coronary cause identified on invasive coronary angiography.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- Acute Coronary Syndrome, Cardiogenic Shock
- Being tested
- Physiological Assessment
- Keywords
- Acute Coronary Syndrome, Cardiogenic Shock, Left ventricle, VA-ECMO
- Medical subject headings
- Acute Coronary Syndrome, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological AssessmentOther
Observational only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physiological Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3 of ECMO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start4 Aug 2022
- Primary completion29 May 2026
- Study completion26 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetris Yannopoulous, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426083
- Sponsor's protocol ID
- CV-2022-30951
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT05426083
- Acronym / sponsor ID
- CV-2022-30951
- Conditions
- Acute Coronary Syndrome, Cardiogenic Shock
- Keywords
- Acute Coronary Syndrome, Cardiogenic Shock, Left ventricle, VA-ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 26 Jul 2026 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiological Assessment | – | Other: Physiological AssessmentProspective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18-75 years of age who were cannulated for VA-ECMO because of ischemic cardiogenic shock (SCAI shock categories D and E)44 per standard clinical practice. Acute coronary syndrome will be verified by the presence of an acute coronary cause identified on invasive coronary angiography.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological AssessmentObservational only | Other | Physiological Assessment |
Primary outcome
Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.
Time frame: Day 3 of ECMO
Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetris Yannopoulous, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Cardiogenic Shock, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support. (time frame: Day 3 of ECMO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.