Phase 2
N=530
Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction
ST Elevation Myocardial Infarction · Inflammatory Response · Myocardial Reperfusion Injury · Myocardial Injury
Bottom Line
View on ClinicalTrials.gov: NCT05462730 ↗Enrolled (actual)
530
Serious AEs
22.1%
Results posted
Mar 2026
Primary outcome: Primary: Final Infarct Size — 5; 6 % of LV
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methylprednisolone (Drug); Isotonic saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Engstrom
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Infarct Size |
5; 6 | — |
| SECONDARY CMR Efficacy: The Extent of MVO |
0.3; 0.6 | — |
| SECONDARY CMR Efficacy: The Extent of Haemorrhage |
54; 63 | — |
| SECONDARY CMR Efficacy: MVO |
92; 115 | — |
| SECONDARY CMR Efficacy: Area at Risk |
28; 30 | — |
| SECONDARY CMR Efficacy: MSI |
55; 50 | — |
| SECONDARY CMR Efficacy: LVEF |
28; 30 | — |
| SECONDARY Peak Troponin-T |
2205; 2840 | — |
| SECONDARY All-cause Mortality |
7; 13 | — |
| SECONDARY Safety: Incidence of Adverse Events |
11; 14 | — |
Summary
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)
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years including fertile women (It is not possible to perform a pregnancy test (HCG urine test) in the pre-hospital setting. However, methylprednisolone is not contraindicated in pregnant women).
- Acute onset of chest pain with 12 hours.
- Known allergy to glucocorticoid or known mental illness with maniac or psychotic episodes.
- Patients with previous acute myocardial infarction (AMI) in the assumed culprit artery.
- Previous coronary artery bypass graft (CABG).
- Unable to read and understand Danish.
Data sourced from ClinicalTrials.gov (NCT05462730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.