SuperSaturated Oxygen Comprehensive Observational Registry

Recruiting now

Conditions studied: STEMI - ST Elevation Myocardial Infarction, AMI

In brief

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility, infarct size reduction, and cost-effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice.

Key facts

Study ID

NCT06438315

Run by

TherOx

People needed

1000

Starts

2024-08-13

Expected to finish

2029-03-31

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects will be excluded if they meet any of the following criteria:
• Life expectancy of less than 2 years
• No access to medical records from either the index hospitalization or subsequent outpatient visits
• Currently participating in an interventional drug or device trial
• cMRI Sub-Study
• At qualifying sites that can perform cMRI scans, subjects who meet the following inclusion and exclusion criteria will be considered for the cMRI sub-study.
• cMRI Inclusion Criteria
• Subjects will be included in the cMRI sub-study must meet all these criteria:
• Meet all the inclusion and exclusion criteria for the overall study
• Consent during index hospitalization to participate in the main study
• cMRI Exclusion Criteria
• Subjects will be excluded from the sub-study if they are contraindicated to MRI, 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; Any indwelling metallic foreign body, shrapnel, or bullet; Any condition contraindicating MRI, including claustrophobia; Inability to follow breath-hold instructions or to maintain a breath-hold for >15 seconds; and Known hypersensitivity or contraindication to gadolinium contrast.

Where it is running

• MemorialCare Orange Coast Medical Center — Fountain Valley, California, United States (enrolling)
• UCSD Health La Jolla - Sulpizio Cardiovascular Center — La Jolla, California, United States (enrolling)
• MemorialCare Saddleback Medical Center — Laguna Hills, California, United States (enrolling)
• MemorialCare Long Beach Medical Center — Long Beach, California, United States (enrolling)
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (enrolling)
• UCSD Hillcrest Medical Center — San Diego, California, United States (enrolling)
• UCLA Santa Monica Medical Center — Santa Monica, California, United States (enrolling)
• Baptist Health Baptist Hospital — Miami, Florida, United States (enrolling)
• NCH Baker Hospital — Naples, Florida, United States (enrolling)
• NCH North Naples — Naples, Florida, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Carle Health Methodist Hospital — Peoria, Illinois, United States (enrolling)
• Ascension Via Christi St Francis — Wichita, Kansas, United States (enrolling)
• Corewell Health Dearborn Hospital — Dearborn, Michigan, United States (enrolling)
• Mercy Hospital — Coon Rapids, Minnesota, United States (enrolling)
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (enrolling)
• United Hospital — Saint Paul, Minnesota, United States (enrolling)
• RWJ- Jersey City Medical Center — Jersey City, New Jersey, United States (enrolling)
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
• North Shore University Hospital — Manhasset, New York, United States (enrolling)
• Long Island Jewish Hospital — Queens, New York, United States (enrolling)
• Charleston Area Medical Center — Charleston, West Virginia, United States (enrolling)
• St Mary's Medical Center — Huntington, West Virginia, United States (enrolling)
• Aurora St Luke's Medical Center — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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