SuperSaturated Oxygen Comprehensive Observational Registry

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
California
MemorialCare Orange Coast Medical Center
RECRUITING
Fountain Valley
UCSD Health La Jolla - Sulpizio Cardiovascular Center
RECRUITING
La Jolla
MemorialCare Saddleback Medical Center
RECRUITING
Laguna Hills
MemorialCare Long Beach Medical Center
RECRUITING
Long Beach
UCSD Hillcrest Medical Center
RECRUITING
San Diego
Florida
Baptist Health Baptist Hospital
RECRUITING
Miami
NCH Baker Hospital
RECRUITING
Naples
NCH North Naples
RECRUITING
Naples
Illinois
University of Chicago
RECRUITING
Chicago
Carle Health Methodist Hospital
RECRUITING
Peoria
Michigan
Corewell Health Dearborn Hospital
RECRUITING
Dearborn
Minnesota
Mercy Hospital
RECRUITING
Coon Rapids
Abbott Northwestern Hospital
RECRUITING
Minneapolis
United Hospital
RECRUITING
Saint Paul
New Jersey
Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
Newark Beth Israel Medical Center
RECRUITING
Newark
New York
North Shore University Hospital
RECRUITING
Manhasset
Long Island Jewish Hospital
RECRUITING
Queens
Wisconsin
Aurora St Luke's Medical Center
RECRUITING
Milwaukee
West Virginia
Charleston Area Medical Center
RECRUITING
Charleston
St Mary's Medical Center
RECRUITING
Huntington
Contact Information
Primary
Jennifer Gardner
sscore.zoll@zoll.com
949-300-2811
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 1000
Treatments
SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
Control
Not treated with SSO2
Sponsors
Leads: TherOx

This content was sourced from clinicaltrials.gov