Cardiology
PHASE2
● Phase II
Phase 2 trial tests steroid pulse for heart attack patients before hospital arrival
ClinicalTrials.gov
Published March 30, 2026
Thomas Engstrom
Researchers conducted a Phase 2 clinical trial to see if a single, strong dose of a steroid (methylprednisolone) could help patients having a major heart attack. The idea was to give the medication in the ambulance, before the patient even reached the hospital for their standard artery-opening procedure (PCI). The goal was to see if this early treatment could calm inflammation and reduce the final amount of permanent damage to the heart muscle.
The study included 530 patients who were having a specific type of severe heart attack called a STEMI. Half received the steroid injection, while the other half received a placebo (saltwater). The main thing researchers wanted to measure was the final size of the heart attack scar. However, the results for this and other outcomes have not been made public yet, so we do not know what the trial found.
Because this is only a Phase 2 trial, its main purpose is to gather initial data on safety and how the body responds to the treatment. We do not have any information yet on side effects or if the steroid caused any problems. It is important to remember that many treatments tested in early trials do not end up being widely used. Readers should understand that this research is still in a very preliminary stage, and no conclusions can be drawn until the full results are published and reviewed.
View Original Abstract ↓
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
