CompletedPhase 2

Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction

Denmark530 participantsStarted 2022-11-14

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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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 duration.
✓. STEMI as characterized on electrocardiogram (ECG) by one of the following:

Exclusion criteria

✕. Presentation with cardiac arrest (out of hospital cardiac arrest (OHCA)).
✕. Time from symptoms onset to primary PCI \> 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.

What they're measuring

Final Infarct Size

Timeframe: 3 months following STEMI

Trial details

NCT IDNCT05462730

SponsorThomas Engstrom

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

Results submitted2024-09-11

View on ClinicalTrials.gov More ST Elevation Myocardial Infarction trials