| Eligibility |
Inclusion Criteria:
- Patients must meet ALL of the following criteria:
GENERAL INCLUSION CRITERIA: Candidates for this study must meet ALL of the following
criteria prior to randomization:
Pre-PCI:
1. The patient must be =18 years of age.
2. Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of
ST-segment elevation myocardial infarction (STEMI).
3. Cardiogenic shock is defined by the presence of at least 2 of the below criteria:
- Hypotension due to a primary cardiac cause (systolic blood pressure [SBP] <90
mmHg refractory to urgent medical care and/or not responsive to initial medical
care or requiring inotropes or vasopressors or mechanical circulatory support to
maintain SBP >90 mmHg)
- Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or
elevated lactate levels)
- Hemodynamic criteria represented by cardiac index <2.2 L/min/m2 or cardiac power
output (CPO) <0.6 W.
4. Patient had pulmonary artery catheters placed for hemodynamic monitoring for clinical
reasons
5. Patient is treated with mechanical circulatory support with an Impella CP.
6. Patient or legally authorized representative has been informed of the nature of the
study, agrees to its provisions and has been provided and signed written or
remote/electronic informed consent, approved by the appropriate Institutional Review
Board (IRB).
7. Patient or legally authorized representative and his/her physician agree to all
required follow-up procedures and visits.
ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the patient has undergone
cardiac catheterization and PCI and has provided signed Informed Consent:
8. Based on coronary anatomy, PCI is indicated for revascularization of the culprit
lesion(s) with use of a commercially available coronary stent (bare metal or
drug-eluting, at operator discretion).
9. Successful angioplasty with stenting is completed <6 hrs from AMI symptom onset, as
documented by less than 30% diameter residual angiographic stenosis within all treated
culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation.
10. For coronary intervention, intravenous antiplatelet agents were used
11. Expected ability to place the SSO2 delivery catheter in the coronary ostium to deliver
SSO2 Therapy with stable, coaxial alignment.
12. Systemic arterial pO2 greater than or equal to 80 mmHg as measured by arterial blood
gas (may be repeated if low after supplemental O2 administration).
Exclusion Criteria:
- Patients will be excluded if ANY of the following conditions apply:
GENERAL EXCLUSION CRITERIA
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.
ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the patient has provided
signed Informed Consent and has undergone cardiac catheterization and PCI if
indicated:
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.
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