Acute Eosinophilic Myocarditis International Registry

Completed

• Conditions: Myocarditis
• Interventions: Other: No intervention

• Registration Number: NCT06447935
• Lead Sponsor: Niguarda Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2021-11-16
• Primary Completion: 2022-06-02
• Study Completion: 2024-05-27
• Study First Submitted: 2024-05-28
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Eosinophilic Myocarditis	No intervention	Patients affected by Acute Eosinophilic Myocarditis with the following inclusion criteria: 1. histologically EM proven "borderline" (presence of inflammatory infiltrate) or "active" (presence of inflammatory infiltrate plus myocardial necrosis) myocarditis, according to the Dallas criteria; 2. acute presentation defined by the onset of cardiac symptoms within 30 days before admission.

Primary Outcome Measures

Name	Time	Method
Natural History of Eosinophilic Myocarditis	3 year	Proportion of patients who die or need a heart transplantation from index admission.

Secondary Outcome Measures

Name	Time	Method
Natural History of Eosinophilic Myocarditis subgroups based on etiology	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,...)

Trial Locations

Locations (1)

ASST GOM Niguarda; 🇮🇹 Milano, Italy