Prehospital pulse-dose methylprednisolone for ST-elevation myocardial infarction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Not yet recruiting
• Skejby, Aarhus University Hospital
  Aarhus, Denmark Not yet recruiting
• Odense University Hospital
  Odense, Denmark Not yet recruiting

Study contacts

• Study coordinator: Jacob Lønborg, MD, PhD, DMSc
• Email: Jacob.Thomsen.Loenborg.01@regionh.dk
• Phone: 35458176

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.