Actively Recruiting

Age: 18Years +
All Genders
NCT06438315

SuperSaturated Oxygen Comprehensive Observational Registry

Led by TherOx · Updated on 2026-04-24

1000

Participants Needed

24

Research Sites

241 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SuperSaturated Oxygen Comprehensive Observational Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 18 years or older
  • Presentation with acute myocardial infarction (AMI) and successful revascularization of the infarct-related artery with PCI
  • Provided written informed consent approved by the Institutional Review Board
  • Primary culprit lesion in the left anterior descending (LAD) coronary tree (for Prospective Control and SSO2 Treated On-Label Cohorts)
  • Successful primary PCI within 6 hours of symptom onset with less than 50% residual stenosis and TIMI Grades 2 or 3 flow
  • No major complications such as perforation, serious bleeding, or cardiogenic shock
  • Not pregnant or nursing
Not Eligible

You will not qualify if you...

  • Life expectancy less than 2 years
  • No access to medical records from the index hospitalization or outpatient visits
  • Currently participating in another investigational drug or device trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 24 locations

1

MemorialCare Orange Coast Medical Center

Fountain Valley, California, United States, 92708

Actively Recruiting

2

UCSD Health La Jolla - Sulpizio Cardiovascular Center

La Jolla, California, United States, 92037

Actively Recruiting

3

MemorialCare Saddleback Medical Center

Laguna Hills, California, United States, 92653

Actively Recruiting

4

MemorialCare Long Beach Medical Center

Long Beach, California, United States, 90806

Actively Recruiting

5

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

6

UCSD Hillcrest Medical Center

San Diego, California, United States, 92103

Actively Recruiting

7

Baptist Health Baptist Hospital

Miami, Florida, United States, 33176

Actively Recruiting

8

NCH Baker Hospital

Naples, Florida, United States, 34102

Actively Recruiting

9

NCH North Naples

Naples, Florida, United States, 34110

Actively Recruiting

10

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

11

Carle Health Methodist Hospital

Peoria, Illinois, United States, 61636

Actively Recruiting

12

Ascension Via Christi St Francis

Wichita, Kansas, United States, 67214

Actively Recruiting

13

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States, 48124

Actively Recruiting

14

Mercy Hospital

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

15

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

16

United Hospital

Saint Paul, Minnesota, United States, 55102

Actively Recruiting

17

RWJ- Jersey City Medical Center

Jersey City, New Jersey, United States, 07302

Actively Recruiting

18

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

19

Newark Beth Israel Medical Center

Newark, New Jersey, United States, 07112

Actively Recruiting

20

North Shore University Hospital

Manhasset, New York, United States, 11030

Actively Recruiting

21

Long Island Jewish Hospital

Queens, New York, United States, 11040

Actively Recruiting

22

Charleston Area Medical Center

Charleston, West Virginia, United States, 25304

Actively Recruiting

23

St Mary's Medical Center

Huntington, West Virginia, United States, 25702

Actively Recruiting

24

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

Actively Recruiting

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Research Team

J

Jennifer Gardner

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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