Acute Eosinophilic Myocarditis International Registry

June 3, 2024 updated by: Niguarda Hospital
Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20162
        • ASST GOM Niguarda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A retrospective observational cohort of eosinophilic myocarditis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Eosinophilic Myocarditis

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.
Other: No intervention
not applicable - no intervention required

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural History of Eosinophilic Myocarditis
Time Frame: 3 year
Proportion of patients who die or need a heart transplantation from index admission.
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,…)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niguarda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Actual)

June 2, 2022

Study Completion (Actual)

May 27, 2024

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIGUARDA H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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