Loading clinical trials...

RECRUITING

SuperSaturated Oxygen Comprehensive Observational Registry

NCT06438315•TherOx

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label or All Others) Cohorts must meet ALL the following baseline criteria:
•Men or women aged 18 years or older
•Presentation with AMI and successful revascularization of the infarct-related artery with PCI
•The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB)
•Treatment with SSO2 Therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. Any subject that is treated with SSO2 Therapy and meets the baseline criteria should be invited to participate in the study.
•Subjects who are in the Prospective Control Cohort as well as subjects enrolled in the SSO2 Treated On-Label Cohort must meet these additional criteria:
•The primary culprit lesion must be in the left anterior descending (LAD) coronary tree
•Successful primary PCI within 6 hours of symptom onset, as documented by \<50% diameter residual angiographic stenosis and Thrombolysis in Myocardial Infarction (TIMI) Grades 2 or 3 flow in the target vessel
•No major complications such as perforation, serious bleeding, or cardiogenic shock
•Not pregnant or nursing

Exclusion Criteria

•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 investigational drug or device trial

Locations (23)

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

Key Dates

Start Date

August 13, 2024

Primary Completion Date

March 1, 2027

Completion Date

March 31, 2029

Last Updated

March 9, 2026

Enrollment

1,000

ESTIMATED participants

Conditions

STEMI - ST Elevation Myocardial InfarctionAMI

Interventions

No intervention

OTHER

Contacts

Jennifer Gardner

CONTACT

949-300-2811 sscore.zoll@zoll.com

A Natural History Study of Bone and Mineral Disorders

NCT00024804

Tumor Induced OsteomalciaOsteomalacia+1 more

View study

RECRUITINGPHASE3

Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

NCT06950385

Familial Adenomatous Polyposis (FAP)

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SuperSaturated Oxygen Comprehensive Observational Registry

Inclusion Criteria

Exclusion Criteria

A Natural History Study of Bone and Mineral Disorders

Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

Fast Discharge After Acute Myocardial Infarction Discharge MI

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

New Care Pathway Using Automated Dynamic Laximetry