Incorporating Supersaturated Oxygen in Shock (ISO-SHOCK)
Cardiogenic Shock, STEMI
About this trial
This is an interventional treatment trial for Cardiogenic Shock focused on measuring Supersaturated Oxygen, SSO2
Eligibility Criteria
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:
- The patient must be ≥18 years of age.
- Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI).
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.
- Patient had pulmonary artery catheters placed for hemodynamic monitoring for clinical reasons
- Patient is treated with mechanical circulatory support with an Impella CP.
- 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).
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:
- 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).
- 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.
- For coronary intervention, intravenous antiplatelet agents were used
- Expected ability to place the SSO2 delivery catheter in the coronary ostium to deliver SSO2 Therapy with stable, coaxial alignment.
- 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:
- A surgical procedure is planned during the first 30 days post-enrollment.
Contraindication to MRI imaging, including any of the following:
- Non-MRI compatible cardiac pacemaker or implantable defibrillator;
- Non-MRI compatible aneurysm clip or other metallic implants;
- Neural Stimulator (i.e., TENS unit);
- Any implanted or magnetically activated device (insulin pump);
- Any type of non-MRI compatible ear implant;
- Metal shavings in the orbits;
- Any indwelling metallic foreign body, shrapnel, or bullet;
- Any condition contraindicating MRI, including claustrophobia;
- Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and
- Known hypersensitivity or contraindication to gadolinium contrast.
- 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
- Evidence of anoxic brain injury on admission (including posturing, seizures, loss of brain stem reflexes)
- Use of IABP
- Septic, anaphylactic, hemorrhagic, or neurologic causes of shock
- Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
- Known previous myocardial infarction, in the same territory as present AMI
- Active bleeding for which mechanical circulatory support is contraindicated.
- Patient has history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary.
- Contraindication to intravenous systemic anticoagulation
- Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
- Known left ventricular thrombus for which mechanical circulatory support with Impella is contraindicated
- Mechanical aortic prosthetic valve or self-expanding TAVR (note: prior bioprosthetic surgical valve or balloon-expandable TAVR implanted >24 hours pre-procedure is acceptable)
- Known impaired renal function (creatinine clearance <30 ml/min/1.73 m2 by the MDRD formula) or on dialysis.
- History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
- Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
- Gastrointestinal or genitourinary bleeding within the last two (2) months.
- Any major surgery (including CABG) within six weeks of enrollment.
- Patient has received any organ transplant or is on a waiting list for any organ transplant.
- Patient has other medical illness (e.g., cancer, dementia) with life expectancy of less than one year.
- Patient has a known hypersensitivity or contraindication to any of the required study medications or contrast that cannot be adequately premedicated.
- 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).
- Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or cardiomyopathy.
- 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.).
- Current participation in other investigational device or drug study that has not reached its primary endpoint.
- Symptoms consistent with isolated right ventricular cardiogenic shock (this study is intended to enroll patients experiencing cardiogenic shock from predominant left ventricular dysfunction).
- Previous enrollment in this study.
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:
- 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.
- Any unrevascularized left main or ostial right coronary artery stenosis >50%, which would preclude use of the delivery catheter.
- Presence of a non-stented coronary dissection with NHLBI grade >B upon completion of the PCI procedure.
Sites / Locations
- Baptist Health South FloridaRecruiting
- Baystate Medical CenterRecruiting
- Henry Ford Health SystemRecruiting
- WakeMedRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Allegheny General HospitalRecruiting
- Prisma Health Greenville Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PCI+Impella plus SSO2
PCI+Impella
Patients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated post-procedure with an infusion of SSO2 Therapy for a duration of 60 minutes.
Patients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated with Standard of Care.