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

Sponsored by Thomas Engstrom

About this trial

Last updated 2 years ago

Study ID

PULSE-MI

Status

Active, not recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 months ago

What is this trial about?

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)

What are the participation requirements?

Yes

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 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.

No

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).

6. Unable to read and understand Danish.

Locations

Location

Status