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Completed

NCT Number: NCT06447935

Acute Eosinophilic Myocarditis International Registry

Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST GOM Niguarda

Milan, 20162, Italy

About this study

Eosinophilic myocarditis (EM) is an acute life-threatening inflammatory disease of the heart. We collect clinical, histologic, laboratory, diagnostic and imaging data regarding acute EM with a histological diagnosis and symptoms onset within 30 days from first medical contact from hospitals around the world. The main objective is to investigate and describe clinical presentation, main systemic conditions associated and outcomes of the first series of patients with acute myocarditis and histological evidence of eosinophilic infiltration within myocardium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients with histological diagnosis gained during an hospitalization within 30 days from symptoms onset.

Treatment and study plan

No intervention

Other

not applicable - no intervention required

Primary outcomes

  1. Natural History of Eosinophilic Myocarditis

    Time frame: 3 year

    Proportion of patients who die or need a heart transplantation from index admission.

Secondary outcomes

  1. Natural History of Eosinophilic Myocarditis subgroups based on etiology

    Time frame: 3 years

    Proportion of patients who die or need a heart transplantation from index admission dividing patients based on the underlying condition (for instance idiopathic, hypersensitivity, eosinophilic granulomatosis with polyangiitis,…)

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jun 7, 2024
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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