Acute Eosinophilic Myocarditis International Registry

Myocarditis Clinical Trial

Official title:

Acute Eosinophilic Myocarditis International Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06447935
• Other study ID #: NIGUARDA H
• Status: Completed
• Start date: November 16, 2021
• Est. completion date: May 27, 2024

Study information

• Verified date: June 2024
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 27, 2024
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Myocarditis

Intervention

Other:
• No intervention
not applicable - no intervention required

Locations

Country	Name	City	State
Italy	ASST GOM Niguarda	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural History of Eosinophilic Myocarditis	Proportion of patients who die or need a heart transplantation from index admission.	3 year
Secondary	Natural History of Eosinophilic Myocarditis subgroups based on etiology	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,…)	3 years