SuperSaturated Oxygen Comprehensive Observational Registry
- Conditions
- AMISTEMI - ST Elevation Myocardial Infarction
- Interventions
- Other: No intervention
- Registration Number
- NCT06438315
- Lead Sponsor
- TherOx
- Brief Summary
The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SuperSaturated Oxygen (SSO2) Therapy No intervention Treated with SSO2 Control No intervention Not treated with SSO2
- Primary Outcome Measures
Name Time Method Cardiovascular (CV) death or Heart Failure (HF) burden at 1 year 1 year Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF
- Secondary Outcome Measures
Name Time Method Rate of all cause mortality 2 years Rate of all cause mortality
Time to Cardiovascular (CV) death or HF burden 2 years Days to the composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF
Change in New York Heart Association (NYHA) classification scale, I-IV 2 years Rate of change of NHYA classification from baseline to time point
Rate of All-cause Hospitalization 2 years Rate of All-cause Hospitalization
Rate of Hospitalization for Heart Failure 2 years Rate of Hospitalization for Heart Failure
Major Adverse Cardiovascular Events (MACE) 2 years composite of rates of CV death, reinfarction, or HF hospitalization
Change in EQ5D-3L Score 2 years Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score 2 years Heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best
Rate of Reinfarction 2 years Rate of Reinfarction
Rate of cardiovascular death 2 years Rate of cardiovascular death
Change in % of Left ventricular ejection fraction (LVEF) 2 years Rate of change of LVEF from baseline to time point
Trial Locations
- Locations (18)
MemorialCare Orange Coast Medical Center
🇺🇸Fountain Valley, California, United States
UCSD Health La Jolla - Sulpizio Cardiovascular Center
🇺🇸La Jolla, California, United States
MemorialCare Saddleback Medical Center
🇺🇸Laguna Hills, California, United States
MemorialCare Long Beach Medical Center
🇺🇸Long Beach, California, United States
UCSD Hillcrest Medical Center
🇺🇸San Diego, California, United States
Baptist Health Baptist Hospital
🇺🇸Miami, Florida, United States
NCH Baker Hospital
🇺🇸Naples, Florida, United States
NCH North Naples
🇺🇸Naples, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Carle Health Methodist Hospital
🇺🇸Peoria, Illinois, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Long Island Jewish Hospital
🇺🇸Queens, New York, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
St Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Aurora St Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States