Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility
- Conditions
- Acute ST Segment Elevation Myocardial Infarction
- Registration Number
- NCT05949515
- Lead Sponsor
- Cardiovascular Research Foundation, New York
- Brief Summary
The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).
- Detailed Description
The TherOx® Downstream® System, which is approved for use in the United States (US) by the Food and Drug Administration (FDA) under P170027. The TherOx® Downstream® System consists of three primary components. These include a hardware device called the TherOx Downstream System ("console"), a single-use disposable device called the TherOx Downstream Cartridge ("cartridge") and a 5 French, commercially available qualified SSO2 infusion coronary delivery catheter ("delivery catheter").
This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
- Data from all patients who received SSO2 treatment and have completed a minimum of 3 months follow up will be collected at each participating center; there are no other exclusion criteria aside from date of treatment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Cardiovascular related Hospitalizations Through study completion, an average of 1 year Between group comparison
Change of Left Ventricular Ejection Fraction Baseline to 3 months Between group comparison
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Northwell Health, Inc
🇺🇸Great Neck, New York, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute
🇺🇸Miami, Florida, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Avita Health
🇺🇸Galion, Ohio, United States
NCH Healthcare System
🇺🇸Naples, Florida, United States
Oakwood Healthcare, Inc
🇺🇸Dearborn, Michigan, United States