Abstract
BACKGROUND: Novel strategies to limit the size of infarction and prevent adverse remodeling and heart failure in patients following acute ST-segment elevation myocardial infarction (STEMI) are lacking. Supersaturated oxygen (SSO(2)) therapy is approved for patients presenting within 6 h of onset of anterior STEMI using femoral artery access. The feasibility of SSO(2) therapy via radial access is unknown. A more detailed understanding of the effect of therapy is needed. OBJECTIVES: To assess the primary outcome, defined as the within-participant change in the plasma concentration of NT-proBNP measured at baseline, 24 h, 2-5 days and 3-months post-MI. DESIGN: Prospective, randomized, controlled, blinded, endpoint (mechanistic, PROBE) clinical trial. RANDOMIZED CONTROLLED TRIAL: After primary PCI, eligible participants will be blinded and randomized 2:1 to either 1 h of SSO(2) therapy using radial artery access and intravenous glycoprotein IIbIIIa inhibitor therapy or a control (sham) procedure involving wrist manipulation in addition to standard care. The primary outcome is the within-participant change in the plasma concentration of NT-proBNP as detailed above. Secondary outcome assessments include coronary microcirculatory function, infarct size, microvascular obstruction, myocardial hemorrhage, left ventricular remodeling, myocardial blood flow, quality of life (EQ-5D-5L), Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Duke Activity Status Index. Patient reported experience measures (PREMS) are an exploratory outcome. Health and economic outcomes will be assessed using electronic healthcare records. VALUE: The study will test the feasibility of radial artery access, provide mechanistic data and inform a larger multicenter trial powered to detect treatment effects on clinical endpoints.Clinicaltrials.gov: NCT06662890.