SuperSaturated Oxygen Comprehensive Observational Registry

Launched by THEROX · May 24, 2024

Keywords

ClinConnect Summary

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) is a clinical study looking at how well SuperSaturated Oxygen (SSO2) Therapy works compared to the standard treatment, which is a procedure called percutaneous coronary intervention (PCI), for patients who have had a heart attack (specifically, a type known as anterior acute myocardial infarction). This study aims to gather real-life data on how SSO2 Therapy affects heart health and how it may ease the burden of heart issues on patients and the healthcare system. By collecting this information, researchers hope to better understand the effectiveness of SSO2 Therapy and how it can be used in everyday medical practice.

To be eligible for this study, participants must be at least 18 years old and have experienced a heart attack that has been treated successfully with PCI. They should not have any serious complications from the procedure and must be able to provide informed consent. Participants will receive either SSO2 Therapy, depending on the doctor's discretion, or standard care, and the study will monitor their health outcomes over time. It's important to note that individuals with a life expectancy of less than two years or those participating in other clinical trials will not be eligible for this study.

Gender

ALL

Eligibility 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