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Prehospital Pulse-dose Glucocorticoid in Patients With ST-segment Elevation Myocardial Infarction 2 - The PULSE-MI 2 Trial

RecruitingPhase 3Ages 18 Years - anyAllThomas Engstrom
NCT07478003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

BACKGROUND Myocardial reperfusion with the use of primary percutaneous coronary intervention (PCI) including stent implantation is the most efficacious treatment for patients with (STEMI) and improves prognosis significantly. Due to continuous improvements in the treatment, the mortality for patients with STEMI has decreased dramatically, but despite these improvements, the mortality rate seems to have reached a plateau at around 10% within 1 year. In addition, 10% develop clinical heart failure with a per se 50% mortality rate within 5 years. Moreover, congestive heart failure is associated with a highly impaired quality of life due to fatigue dyspnea and reduced exercise capacity. Thus, there is a need for further improvement in the treatment to drive the event rates further down. One such key target is reducing the damage to the heart muscle (infarct size) to preserve the heart functi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years including fertile women * Acute onset of chest pain with \< 24 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 elevation 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 indicating posterior acute myocardial infarction (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 Exclusion Criteria: * Suspected other type I acute myocardial infarction at time of potential randomization * Initial presentation with cardiac arrest (out of hospital cardiac arrest) * Known allergy to glucocorticoid
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What it tests

  • Methylprednisolone 250 mg
  • NaCl (0,9%)
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Where

4 sites
Aalborg University Hospital
Aalborg, Denmark
Skejby, Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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