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

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Engstrom
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. 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).

2. Acute onset of chest pain with < 12 hours duration.

3. STEMI as characterized on electrocardiogram (ECG) by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm con-cordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI).

Exclusion Criteria:

1. Presentation with cardiac arrest (out of hospital cardiac arrest (OHCA)).

2. Time from symptoms onset to primary PCI > 12 hours.

3. Known allergy to glucocorticoid or known mental illness with maniac or psychotic episodes.

4. Patients with previous acute myocardial infarction (AMI) in the assumed culprit artery.

5. Previous coronary artery bypass graft (CABG).