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Registry evaluating SuperSaturated Oxygen Therapy for heart attack treatment

SuperSaturated Oxygen Comprehensive Observational Registry

Observational TherOx · NCT06438315

This study is testing whether SuperSaturated Oxygen Therapy can help people who have had a heart attack feel better compared to standard treatments.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorTherOx Industry-sponsored
Locations24 sites (Fountain Valley, California and 23 other locations)
Trial IDNCT06438315 on ClinicalTrials.gov

What this trial studies

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) is designed to assess the effectiveness of SuperSaturated Oxygen (SSO2) Therapy compared to standard percutaneous coronary intervention (PCI) in patients with anterior acute myocardial infarction (AMI). This observational study will collect real-world data on the impact of SSO2 Therapy on heart failure burden and healthcare resource utilization. By analyzing this data, the registry aims to provide insights into the clinical utility of SSO2 Therapy in routine practice.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18 and older who have experienced an acute myocardial infarction and have undergone successful revascularization.

Not a fit: Patients who do not meet the inclusion criteria or those who are not treated with SSO2 Therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment options for patients with acute myocardial infarction, potentially reducing heart failure rates.

How similar studies have performed: While this approach is observational, similar studies evaluating novel therapies in acute myocardial infarction have shown promising results, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Fountain Valley, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions STEMI - ST Elevation Myocardial InfarctionAMI
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.