Phase 2 trial tests pre-hospital glucocorticoid pulse in STEMI patients undergoing primary PCI

Status: COMPLETED | Phase: PHASE2 Condition(s): ST Elevation Myocardial Infarction, Inflammatory Response, Myocardial Reperfusion Injury, Myocardial Injury Intervention(s): Methylprednisolone (DRUG), Isotonic saline (DRUG) The overall primary objective of the PULSE-MI trial is to test the hypothesis that administration of single-dose glucocorticoid pulse therapy in the pre-hospital setting reduces final infarct size in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) Detailed: BACKGROUND Myocardial reperfusion with the use of primary percutaneous coronary intervention (PCI) including stent implantation is the most efficacious treatment for patients with (STEMI) and improves prognosis significantly. Due to continuous improvements in the treatment, the mortality for patients with STEMI has decreased dramatically, but despite these improvements, the mortality rate seems to have reached a plateau at around 10% within 1 year. In addition, 10% develop clinical heart failure with a per se 50% mortality rate within 5 years. Moreover, congestive heart failure is associated with a highly impaired quality of life due to fatigue dyspnea and reduced exercise capacity. Thus, there is a need for further improvement in the treatment to drive the event rates further down. One su Primary Outcome(s): Final Infarct Size Enrollment: 530 (ACTUAL) Lead Sponsor: Thomas Engstrom Start: 2022-11-14 | Primary Completion: 2024-01-30 Results posted: 2026-03-27