NCT06447935

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

May 28, 2024

Last Update Submit

June 3, 2024

Conditions

Myocarditis

Keywords

Eosinophilic MyocarditisEndomyocardial Biopsy

Outcome Measures

Primary Outcomes (1)

  • Natural History of Eosinophilic Myocarditis

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

    3 year

Secondary Outcomes (1)

  • Natural History of Eosinophilic Myocarditis subgroups based on etiology

    3 years

Study Arms (1)

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

Interventions

No interventionOTHER

not applicable - no intervention required

Acute Eosinophilic Myocarditis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A retrospective observational cohort of eosinophilic myocarditis patients

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

ASST GOM Niguarda

Milan, 20162, Italy

Location

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 7, 2024

Study Start

November 16, 2021

Primary Completion

June 2, 2022

Study Completion

May 27, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations

IT(1)