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Updated: Jul 8, 2025
Postconditioning with Lactate-enriched Blood for Cardioprotection in ST-segment Elevation Myocardial Infarction
Published on: May 28, 2019
Pre-hospital pulse glucocorticoid therapy in patients with ST-segment elevation myocardial infarction transferred for
Jasmine Melissa Madsen1, Laust Emil Roelsgaard Obling2, Laura Rytoft2
1Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. jasmine.melissa.madsen.01@regionh.dk.
Insights
Pre-hospital methylprednisolone may reduce heart damage in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI. This study investigates its cardioprotective effects by measuring final infarct size.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Inflammation significantly contributes to myocardial ischemia and reperfusion injury in STEMI patients post-PCI.
- Methylprednisolone, a potent anti-inflammatory glucocorticoid, is effective in treating various acute conditions.
- Pre-hospital administration of methylprednisolone is being investigated for its potential cardioprotective effects in STEMI.
Purpose of the Study:
- To investigate the cardioprotective effects of pulse-dose methylprednisolone administered pre-hospital.
- To determine if pre-hospital methylprednisolone reduces final infarct size in STEMI patients treated with primary PCI.
Main Methods:
- A randomized, blinded, placebo-controlled, prospective clinical phase II trial.
- 378 STEMI patients will be randomized to receive either 250 mg methylprednisolone or placebo intravenously pre-hospital.
- Primary outcome is final infarct size assessed by cardiac magnetic resonance (CMR) at 3 months; secondary outcomes include CMR parameters, clinical endpoints, biomarkers, and safety.
Main Results:
- This section is not yet available as the trial is ongoing.
Conclusions:
- The study hypothesizes that pre-hospital methylprednisolone will decrease inflammation and reduce final infarct size in STEMI patients undergoing primary PCI.
Background:
Inflammation in ST-segment elevation myocardial infarction (STEMI) is an important contributor to both acute myocardial ischemia and reperfusion injury after primary percutaneous coronary intervention (PCI). Methylprednisolone is a glucocorticoid with potent anti-inflammatory properties with an acute effect and is used as an effective and safe treatment of a wide range of acute diseases. The trial aims to investigate the cardioprotective effects of pulse-dose methylprednisolone administered in the pre-hospital setting in patients with STEMI transferred for primary PCI.
Methods:
This trial is a randomized, blinded, placebo-controlled prospective clinical phase II trial. Inclusion will continue until 378 patients with STEMI have been evaluated for the primary endpoint. Patients will be randomized 1:1 to a bolus of 250 mg methylprednisolone intravenous or matching placebo over a period of 5 min in the pre-hospital setting. All patients with STEMI transferred for primary PCI at Rigshospitalet, Copenhagen University Hospital, Denmark, will be screened for eligibility. The main eligibility criteria are age ≥ 18 years, acute onset of chest pain with < 12 h duration, STEMI on electrocardiogram, no known allergy to glucocorticoids or no previous coronary artery bypass grafting, previous acute myocardial infarction in assumed culprit, or a history with previous maniac/psychotic episodes. Primary outcome is final infarct size measured by late gadolinium enhancement on cardiac magnetic resonance (CMR) 3 months after STEMI. Secondary outcomes comprise key CMR efficacy parameters, clinical endpoints at 3 months, the peak of cardiac biomarkers, and safety.
Discussion:
We hypothesize that pulse-dose methylprednisolone administrated in the pre-hospital setting decreases inflammation and thus reduces final infarct size in patients with STEMI treated with primary PCI.
Trial Registration:
EU-CT number: 2022-500762-10-00; Submitted May 5, 2022.
Clinicaltrials:
gov Identifier: NCT05462730; Submitted July 7, 2022, first posted July 18, 2022.
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