Cardiogenic Shock, STEMI
Conditions
Keywords
Supersaturated Oxygen, SSO2
Brief summary
A multi-center, prospective randomized (1:1) pilot and feasibility study to evaluate the safety and feasibility of supersaturated oxygen (SSO2) therapy delivered for 60 minutes selectively into the culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock (STEMI-CS) treated using a shock protocol.
Interventions
DEVICESSO2 Downstream System
60-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting.
PROCEDUREPCI + Impella
Standard of Care Intervention
Sponsors
TherOx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality at 30-days in the SSO2 group rate compared with the control group rate | 30 days | Primary Safety Endpoint |
Countries
United States
Outcome results
None listed