Trial overview

Summary

The aim of this nationwide trial is to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality compared with placebo in patients with STEMI

Interventions

Patients will be randomized 1:1 in the prehospital setting to either:

1. Glucocorticoid (250 mg methylprednisolone)

2. Placebo (0.9% NaCl)

Both glucocorticoid and placebo will be administered over a period of 5 minutes during transportation. All subsequent care including primary PCI, antithrombotic therapy, and guideline-based follow-up treatment will be performed according to standard clinical practice.

Inclusion criteria

Age ≥18 years

Acute onset of chest pain with <24 hours duration

STEMI on ECG

Exclusion criteria

Suspected other type I acute myocardial infarction

Initial presentation with cardiac arrest

Known allergy to glucocorticoid

Blinding

The trial is blinded for patients, prehospital personel and physicians performing subsequent care.

Ethical considerations

The study has been approved by the ethics committee, registered with the Danish Data Protection Agency, conducted according to the Declaration of Helsinki, and is monitored by local GCP-units. Due to the emergency nature of STEMI, treatment will be initiated before consent; informed consent will be obtained as soon as possible after PCI, with representative consent used when required, following established practice in comparable acute trials. The intervention poses minimal risk, does not delay standard care, and may provide clinical benefit.