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Not yet recruiting NCT07501481

Arrhythmic Risk in Myocarditis Outcome Research

— Observational Myocarditis Acute Ventricular Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment of acute myocarditis.
Who it may be relevant to
Registry conditions: Myocarditis Acute, Ventricular Arrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Incidence, Clinical Impact, and Prediction of Ventricular Arrhythmia in Patients With Acute Myocarditis

Overview

The goal of this observational, retrospective, multicenter study is to characterize the arrhythmic burden and identify predictive factors for ventricular arrhythmias (VAs) in adult patients hospitalized for acute myocarditis (AM). The main questions it aims to answer are: * What is the incidence of sustained ventricular arrhythmias during the index hospitalization in patients with acute myocarditis? * What clinical, biological, electrocardiographic, and imaging factors predict the occurrence of sustained ventricular arrhythmias during hospitalization and after discharge? Researchers will compare patients who developed sustained VAs during hospitalization to those who did not, in order to identify independent predictors of arrhythmic events and develop a validated risk stratification score. Participants' medical records from 2020 to 2024 will be reviewed to collect: * Baseline demographic, clinical, biological, electrocardiographic, and imaging data at admission * In-hospital management strategies and outcomes, including mortality, cardiogenic shock, and heart replacement therapy * Long-term follow-up data including VA recurrence, sudden cardiac death, and development of cardiomyopathy, with censoring applied on January 1, 2026

Interventions

  • Other Treatment of acute myocarditis
    Standard medical and interventional management of acute myocarditis in accordance with local protocols

Primary outcome measures

  • Ventricular arrhythmia [Time frame: through study completion, an average of 3 years]
Secondary outcome measures (1)
  • Cardiomyopathy [Time frame: through study completion, an average of 3 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Hospitalization for acute myocarditis
  • Confirmation of the diagnosis of AM by at least one of the following: (1) Cardiac magnetic resonance according to the revised 2018 Lake Louise Criteria; (2) Endomyocardial biopsy according to the Dallas criteria with associated immunohistochemical and molecular criteria; (3) Cardiac computed tomography with compatible late iodine enhancement

Exclusion criteria

  • Age < 18 years
  • Concomitant acute coronary syndrome

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07501481 · 2025-137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗