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NCT05462730CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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)

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
530 (actual)
First submitted
7 Jul 2022
Start date
14 Nov 2022
Primary completion date
30 Jan 2024
Lead sponsor
Thomas Engstrom
NCT number
NCT05462730
EU CT number
2022-500762-10-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 530
  • From 14 Nov 2022 to the primary completion date, 30 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with previous acute myocardial infarction (AMI) in the assumed culprit artery.
  • Previous coronary artery bypass graft (CABG).

Other illness

  • Presentation with cardiac arrest (out of hospital cardiac arrest (OHCA)).
  • Known allergy to glucocorticoid or known mental illness with maniac or psychotic episodes.

Other

  • Time from symptoms onset to primary PCI \> 12 hours.
  • Unable to read and understand Danish.

Who the study is looking for

  • 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:
    • 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 ele-vation 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 and ST-segment elevation (≥0.5 mm) in posterior chest wall leads V7-V9 indicating posterior acute myocardial infarc-tion (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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Heart Center, Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.