Study of Prehospital Pulse-Dose Methylprednisolone to Reduce Death in Patients with ST-Elevation Myocardial Infarction

What this Trial Is About

Researchers are evaluating the effect of prehospital pulse-dose glucocorticoid therapy in patients experiencing ST-segment elevation myocardial infarction STEMI, a serious heart condition treated by primary percutaneous coronary intervention PCI. Despite improvements in PCI, mortality rates and heart failure after STEMI remain significant concerns. Inflammation during reperfusion injury contributes to heart muscle damage, and glucocorticoids may help reduce this inflammation to protect heart function and reduce mortality. The study compares two treatment groups one receiving a prehospital infusion of 250 mg methylprednisolone a glucocorticoid and the other receiving a placebo of 0.9% NaCl. Both infusions are administered over 5 minutes during ambulance transport before PCI. This phase 3 randomized, quadruple-blinded trial plans to enroll 5204 patients to assess the impact of early glucocorticoid treatment on survival and heart outcomes. Participants will be monitored for outcomes including all-cause mortality one year after the last patient is included, along with cardiovascular mortality, heart failure admissions, and recurrent heart events. The median follow-up is expected to be 3 years, with a minimum of 1 year. Safety, heart function, and event rates will be tracked through clinical evaluations and data collection during the follow-up period to understand the treatments potential benefits.

Prehospital Pulse-dose Glucocorticoid in Patients With ST-segment Elevation Myocardial Infarction 2 - The PULSE-MI 2 Trial