SuperSaturated Oxygen Comprehensive Observational Registry

Recruiting

• Conditions: AMI; STEMI - ST Elevation Myocardial Infarction

• 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

Study Timeline

• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-31
• Study Start: 2024-08-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03
• Primary Completion: 2027-03
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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
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 all cause mortality	2 years	Rate of all cause mortality
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
Rate of Reinfarction	2 years	Rate of Reinfarction
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 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 (19)

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

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