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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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