Observational Study of SuperSaturated Oxygen Therapy Compared to PCI Alone in Adults With Anterior Heart Attacks

What this Trial Is About

Researchers are evaluating the clinical utility and cost-effectiveness of SuperSaturated Oxygen SSO2 Therapy compared to standard percutaneous coronary intervention PCI alone in patients with anterior acute myocardial infarction AMI. The study aims to collect real-world data on how SSO2 Therapy affects heart failure burden and infarct size reduction, which may impact patients and healthcare systems. The study is observational and focuses on patients treated in routine clinical practice. Participants are grouped based on whether they receive SSO2 Therapy or not, allowing comparison between those treated with this therapy and those receiving usual care. The study includes a sub-study involving cardiac MRI cMRI scans at selected sites to assess heart damage more closely. Various quality of life questionnaires, such as the Kansas City Cardiomyopathy Questionnaire KCCQ and EQ5D, are also used to evaluate patient outcomes. During the study, participants will be monitored for outcomes including cardiovascular death and heart failure burden over a median of 1.5 years, as well as infarct size measured 2 to 7 days after PCI. Other assessments include rates of hospitalization, mortality, and changes in quality of life scores over two years. The study collects comprehensive data to analyze the effectiveness and healthcare resource use associated with SSO2 Therapy in AMI patients, with follow-up lasting up to two years or more.

SuperSaturated Oxygen Comprehensive Observational Registry