NCT04876040
Withdrawn
N/A
A Multi-Center Randomized-Controlled Trial To Evaluate The Safety And Feasibility of The Delivery Of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy For 60 Minutes In Patients With St Elevation Myocardial Infarction (STEMI) And Cardiogenic Shock After Successful Reperfusion (Via PCI) ≤ Six Hours After Symptom Onset Compared To Standard Therapy
TherOx7 sites in 1 countryDecember 17, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiogenic Shock
- Sponsor
- TherOx
- Locations
- 7
- Primary Endpoint
- All cause mortality at 30-days in the SSO2 group rate compared with the control group rate
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
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:
- •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.
Exclusion Criteria
- •Patients will be excluded if ANY of the following conditions apply:
- •GENERAL EXCLUSION CRITERIA
- •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;
Outcomes
Primary Outcomes
All cause mortality at 30-days in the SSO2 group rate compared with the control group rate
Time Frame: 30 days
Primary Safety Endpoint
Study Sites (7)
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