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

NCT05462730 | Completed Phase 2 Results DMC

• 2 other identifiers: PULSE-MI2022-500762-10-00
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Inflammatory Response; Myocardial Injury; ST Elevation Myocardial Infarction; Myocardial Reperfusion Injury

Keywords

Primary PCI; Inflammation; Reperfusion Injury; Methylprednisolone; Solu-Medrol; Cardioprotection

Outcome Measures

Primary Outcomes (1)

• Final Infarct Size

  % of the left ventricle mass measured by late-gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR)

  3 months following STEMI

Secondary Outcomes (9)

• CMR Efficacy: The Extent of MVO

  During admission

• CMR Efficacy: The Extent of Haemorrhage

  During admission

• CMR Efficacy: MVO

  During admission

• CMR Efficacy: Area at Risk

  During admission

• CMR Efficacy: MSI

  During admission and 3 months following STEMI

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

A five minutes bolus infusion of 250 mg (4 mL) methylprednisolone to inhibit inflammatory damage following ST-segment elevation myocardial infarction. The infusion of methylprednisolone will be given in the pre-hospital setting prior to primary PCI.

Drug: Methylprednisolone

Isotonic saline

PLACEBO COMPARATOR

A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).

Drug: Isotonic saline

Interventions

Isotonic saline DRUG

A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).

Also known as: Isotonic NaCl, Placebo

Isotonic saline

Methylprednisolone DRUG

A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.

Also known as: Solu-Medrol

Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Engstrom: lead

Study Sites (1)

Heart Center, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Related Publications (2)

• Marquard JM, Lonborg J, Obling LER, Beske RP, Zhou Y, Nepper-Christensen L, Vejlstrup N, Bang LE, Hassager C, Folke F, Andersen LB, Christensen HC, Holmvang L, Pedersen F, Ahlehoff O, Jabbari R, Minkkinen M, Sorensen R, Tilsted HH, Engstrom T. Prehospital pulse-dose glucocorticoid on index of microvascular resistance in patients with ST-segment elevation myocardial infarction: a sub-study of the PULSE-MI trial. J Inflamm (Lond). 2025 Mar 18;22(1):12. doi: 10.1186/s12950-025-00440-2.

  PMID: 40102868 DERIVED

• Madsen JM, Engstrom T, Obling LER, Zhou Y, Nepper-Christensen L, Beske RP, Vejlstrup NG, Bang LE, Hassager C, Folke F, Kyhl K, Andersen LB, Christensen HC, Rytoft L, Arslani K, Holmvang L, Pedersen F, Ahlehoff O, Jabbari R, Barfod C, Hougaard M, Minkkinen M, Tilsted HH, Sorensen R, Lonborg JT. Prehospital Pulse-Dose Glucocorticoid in ST-Segment Elevation Myocardial Infarction: The PULSE-MI Randomized Clinical Trial. JAMA Cardiol. 2024 Oct 1;9(10):882-891. doi: 10.1001/jamacardio.2024.2298.

  PMID: 39211964 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Reperfusion Injury; Inflammation; Reperfusion Injury

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies; Postoperative Complications

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jasmine Melissa Madsen
• Organization: Rigshospitalet

jasmine.melissa.madsen.01@regionh.dk

004535453559

Study Officials

• Jacob T Lønborg, MD, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Jasmine M Madsen, MD

  Rigshospitalet, Denmark

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, Ph.D., DMSc

Model Details: Investigator-initiated, 1:1 randomized, multicenter, double-blind, placebo-controlled clinical trial. A minimum of 378 patients with STEMI will be randomized 1:1 to an infusion of 250 mg (4 mL) methylprednisolone in the pre-hospital setting prior to primary PCI. The methylprednisolone will be given as a bolus infusion of 1 x 250 mg (1 x 4 mL) over a period of 5 minutes. Patients allocated to placebo will receive 4 mL of isotonic saline (NaCl 0.9%).

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 18, 2022
• Study Start: November 14, 2022
• Primary Completion: January 30, 2024
• Study Completion: October 17, 2024
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)