Evidence map›Paper›PMID 38102687›Full record

Trial reportTrials2023

Pre-hospital pulse glucocorticoid therapy in patients with ST-segment elevation myocardial infarction transferred for primary percutaneous coronary intervention: a randomized controlled trial (PULSE-MI).

Jasmine Melissa Madsen, Laust Emil Roelsgaard Obling, Laura Rytoft, Fredrik Folke, Christian Hassager, Lars Bredevang Andersen, Niels Vejlstrup, Lia Evi Bang, Thomas Engstrøm, Jacob Thomsen Lønborg

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05462730 phase2completednot on this map

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

TypeinterventionalSponsorThomas EngstromRan2022 to 2024Enrolled530ConditionsST Elevation Myocardial Infarction, Inflammatory Response, Myocardial Reperfusion Injury, Myocardial InjuryArmsMethylprednisolone, Isotonic saline
NCT07478003 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

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

TypeinterventionalSponsorThomas EngstromRan2026 to 2036Enrolled5,204ConditionsSTEMI - ST Elevation Myocardial InfarctionArmsMethylprednisolone 250 mg, NaCl (0,9%)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Jasmine Melissa MadsenDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. jasmine.melissa.madsen.01@regionh.dk.ORCID http://orcid.org/0000-0003-2299-7377
Laust Emil Roelsgaard OblingDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Laura RytoftDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Fredrik FolkeCopenhagen Emergency Medical Services, Copenhagen, Denmark, and Department of Cardiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark.
Christian HassagerDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Lars Bredevang AndersenRegion Zealand Emergency Medical Services, Naestved, Denmark.
Niels VejlstrupDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Lia Evi BangDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Thomas EngstrømDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Jacob Thomsen LønborgDepartment of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Copenhagen University Hospital · DKRegion Zealand · DK

Funding

Rigshospitalet E-22670-08
6 · The paper itself

Abstract

backgroundInflammation 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.

methodsThis 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 registrationEU-CT number: 2022-500762-10-00; Submitted May 5, 2022. CLINICALTRIALS: gov Identifier: NCT05462730; Submitted July 7, 2022, first posted July 18, 2022.

Indexed as

Myocardial InfarctionPercutaneous Coronary InterventionST Elevation Myocardial InfarctionAdolescentAdultContrast MediaGadoliniumGlucocorticoidsHospitalsHumansInflammationMethylprednisoloneProspective StudiesTreatment OutcomeContrast MediaGadoliniumGlucocorticoidsMethylprednisoloneCardiac magnetic resonanceCardioprotectionInflammationPre-hospital interventionRandomized controlled trialsReperfusion InjurySteroidST-segment elevation myocardial infarction

Identifiers

PMID38102687
PMCPMC10724922
OpenAlexW4389819993

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.