Incorporating Supersaturated Oxygen in Shock

Exclusion Criteria

• •Patients will be excluded if ANY of the following conditions apply:
• •Pre-PCI:
• •1. A surgical procedure is planned during the first 30 days post-enrollment.
• •2. Contraindication to MRI imaging, including any of the following:
• •1. Non-MRI compatible cardiac pacemaker or implantable defibrillator;
• •2. Non-MRI compatible aneurysm clip or other metallic implants;
• •3. Neural Stimulator (i.e., TENS unit);
• •4. Any implanted or magnetically activated device (insulin pump);
• •5. Any type of non-MRI compatible ear implant;
• •6. Metal shavings in the orbits;
• •7. Any indwelling metallic foreign body, shrapnel, or bullet;
• •8. Any condition contraindicating MRI, including claustrophobia;
• •9. Inability to follow breath hold instructions or to maintain a breath hold for \>15 seconds; and
• •10. Known hypersensitivity or contraindication to gadolinium contrast.
• •3. All unwitnessed out of hospital cardiac arrest or any witnessed cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes or any neurological injury
• •4. Evidence of anoxic brain injury on admission (including posturing, seizures, loss of brain stem reflexes)
• •5. Use of IABP
• •6. Septic, anaphylactic, hemorrhagic, or neurologic causes of shock
• •7. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
• •8. Known previous myocardial infarction, in the same territory as present AMI
• •9. Active bleeding for which mechanical circulatory support is contraindicated.
• •10. Patient has history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary.
• •11. Contraindication to intravenous systemic anticoagulation
• •12. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
• •13. Known left ventricular thrombus for which mechanical circulatory support with Impella is contraindicated
• •14. Mechanical aortic prosthetic valve or self-expanding TAVR (note: prior bioprosthetic surgical valve or balloon-expandable TAVR implanted \>24 hours pre-procedure is acceptable)
• •15. Known impaired renal function (creatinine clearance \<30 ml/min/1.73 m2 by the MDRD formula) or on dialysis.
• •16. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
• •17. Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
• •18. Gastrointestinal or genitourinary bleeding within the last two (2) months.
• •19. Any major surgery (including CABG) within six weeks of enrollment.
• •20. Patient has received any organ transplant or is on a waiting list for any organ transplant.
• •21. Patient has other medical illness (e.g., cancer, dementia) with life expectancy of less than one year.
• •22. Patient has a known hypersensitivity or contraindication to any of the required study medications or contrast that cannot be adequately premedicated.
• •23. Patient with severe peripheral arterial disease in whom mechanical circulatory support cannot be safely established (or who require a smaller device such as an IABP).
• •24. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or cardiomyopathy.
• •25. Patient is a member of a vulnerable population or has any significant medical or social condition which in the investigator's opinion may interfere with the patient's participation in the study or ability to comply with follow-up procedures, including MRI (e.g. alcoholism, dementia, lives far from the research center, etc.).
• •26. Current participation in other investigational device or drug study that has not reached its primary endpoint.
• •27. Symptoms consistent with isolated right ventricular cardiogenic shock (this study is intended to enroll patients experiencing cardiogenic shock from predominant left ventricular dysfunction).
• •28. Previous enrollment in this study.
• •29. Subject is currently hospitalized for definite or suspected COVID-19.
• •30. Left ventriculography or high-quality echocardiography (at least one of which is mandatory either before or after PCI, but in all cases before randomization) demonstrates severe mitral regurgitation with concerns of papillary muscle rupture, a ventricular septal defect, a pseudoaneurysm, aortic dissection or other mechanical complications of MI.
• •31. Any unrevascularized left main or ostial right coronary artery stenosis \>50%, which would preclude use of the delivery catheter.
• •32. Presence of a non-stented coronary dissection with NHLBI grade \>B upon completion of the PCI procedure.