Stopped: The study could not be started due to a lack of funding for the provision of the medical product to be investigated.
The HOT-AAMI study investigates the efficacy of supersaturated oxygen therapy (SSO2) as an adjunct to standard percutaneous coronary intervention (PCI) with stent implantation in patients suffering from acute anterior myocardial infarction (AMI). This is a prospective, open-label, multicenter, two-arm, randomized (1:1) clinical trial conducted in Germany. Objective: The primary aim is to assess whether SSO2 therapy reduces the risk of mortality and heart failure progression after PCI compared to PCI alone. Secondary endpoints include cardiac morbidity, quality of life (Kansas City Cardiomyopathy Questionnaire), and adverse events over 12 months. Study Design: The trial involves 1,266 patients randomized to receive either the SSO2 therapy post-PCI or PCI alone. Participants must be adults with acute anterior AMI and undergo successful PCI within 6 hours of symptom onset. Recruitment is expected to span 36 months with a follow-up period of 12 months for each participant. Intervention and Control: Intervention group: SSO2 therapy delivered intracoronary using hyperoxygenated blood. Control group: Standard PCI with stent placement without adjunctive therapy. Primary Endpoint: The combined outcome of all-cause mortality or unplanned hospital/ambulatory visits for heart failure requiring intravenous diuretics within 12 months post-randomization. Background and Rationale: AMI treatment often leaves significant myocardial damage despite successful PCI. Prior studies on SSO2 therapy have demonstrated potential benefits, including reduced infarct size and improved myocardial function, with evidence suggesting reduced heart failure rates and improved long-term survival. Statistical Power: The study anticipates a primary endpoint event rate of 16% in the control group, with a hypothesized hazard reduction of 25% in the intervention group. A total of 393 events across 1,266 patients are needed to achieve an 80% power at a 5% significance level. Safety and Monitoring: A Data Safety Monitoring Board (DSMB) will oversee the trial. Adverse events will be documented and reported according to protocol guidelines. Expected Outcomes: If successful, the study may provide evidence for integrating SSO2 therapy into clinical practice, potentially lowering mortality and morbidity in AMI patients, with implications for both patient care and healthcare costs.
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all-cause mortality or unplanned heart failure hospital admission or unplanned outpatient visit due to heart failure requiring intravenous diuretic therapy
Timeframe: 12 months after the last patient is enrolled