Prehospital pulse-dose methylprednisolone for ST-elevation myocardial infarction

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

We will test if a single high dose of methylprednisolone given before hospital arrival can reduce heart muscle damage in adults having an ST-elevation heart attack.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5204 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 4 sites (Aalborg and 3 other locations)
• Trial ID: NCT07478003 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized interventional trial gives a single 250 mg IV dose of methylprednisolone or saline in the prehospital setting to adults with ECG-confirmed STEMI. Patients are enrolled by emergency services and transported to participating Danish university hospitals for primary PCI and standardized follow-up. The primary intent is to see whether the steroid reduces infarct size and subsequent rates of heart failure and death after reperfusion. The trial is run across multiple centers including Aalborg, Aarhus, Odense and Rigshospitalet.

Who should consider this trial

Good fit: Adults aged 18 or older with acute chest pain and ECG-confirmed STEMI within 24 hours who are reachable by prehospital emergency services and eligible for primary PCI.

Not a fit: People with other types of myocardial infarction, symptoms longer than 24 hours, contraindications to steroids (such as active infection or uncontrolled diabetes), or who cannot be reached by participating EMS are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could reduce heart muscle damage, lower the risk of heart failure and death, and improve recovery after a STEMI.

How similar studies have performed: Previous anti-inflammatory approaches in acute MI have produced mixed results, and giving a pulse dose of glucocorticoid in the prehospital phase is relatively novel and unproven in large phase 3 trials.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years including fertile women
* Acute onset of chest pain with \< 24 hours duration
* STEMI as characterized on electrocardiogram (ECG) by one of the following:

  1. at least two contiguous leads with ST-segment elevation ≥2.5 mm in men \< 40 years, ≥2 mm in men ≥40 years, or ≥1.5 mm in women in leads V2-V3 and/or ≥1 mm in the other leads,
  2. presumed new left bundle branch block with ≥1 mm concordant ST-segment elevation in leads with a positive QRS complex, or concordant ST-segment depression ≥1 mm in V1-V3, or discordant ST-segment elevation ≥5 mm in leads with a negative QRS complex
  3. Isolated ST depression ≥0.5 mm in leads V1-V3 indicating posterior acute myocardial infarction (AMI)
  4. ST-segment depression ≥1 mm in eight or more surface leads, coupled with ST-segment elevation in aVR and/or V1 suggesting left main-, or left main equivalent- coronary obstruction

Exclusion Criteria:

* Suspected other type I acute myocardial infarction at time of potential randomization
* Initial presentation with cardiac arrest (out of hospital cardiac arrest)
* Known allergy to glucocorticoid

Where this trial is running

Aalborg and 3 other locations

• Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
• Skejby, Aarhus University Hospital — Aarhus, Denmark (Not_yet_recruiting)
• Rigshospitalet — Copenhagen, Denmark (Recruiting)
• Odense University Hospital — Odense, Denmark (Not_yet_recruiting)

Study contacts

• Study coordinator: Jacob Lønborg, MD, PhD, DMSc

Conditions STEMI - ST Elevation Myocardial Infarction; STEMI; Prehospital Intervention; Glucocorticoids