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临床试验/NCT04589156
NCT04589156Unknown不适用

Recurrent Acute Myocarditis : Characteristics, Etiology, Prognosis and Genetic Basis.

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Sustained ventricular arrhythmia

研究概览

简要总结

The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

详细描述

Acute myocarditis (AM) is an inflammatory disease of the myocardium caused by different infectious and non-infectious triggers. It is a major cause of sudden cardiac death, with also long-term adverse outcomes in survivors. The incidence and predictive factors of recurrent AM (RAM) are unknown.

Arrhythmogenic cardiomyopathy (ACM) is a genetically-determined or acquired arrhythmogenic disorder of the myocardium. With an incidence of 1/5000, genetic ACM is the consequence of pathogenic variants in genes encoding for desmosomal and cytoskeleton proteins. Originally described as a right ventricular disease (ARVC), genetic ACM is increasingly recognized as a left (ALVC) or biventricular entity. Genetic ACM may manifest with various clinical presentations, with a predisposition to acute and chronic heart failure, ventricular arrhythmias and sudden cardiac death. Pathophysiology of genetic ACM at early stages remain widely elusive.

Myocardial inflammation has been consistently reported in patients with genetic ACM, but the exact nature of their association is a matter of debate. The temporal association between RAM episodes and the later diagnosis of genetic ACM is speculative, and it has been hypothesized recently that RAM episodes might reflect early active phases in the development of a genetic ACM.

The investigators aim to study the temporal association between RAM episodes and the later diagnosis of an ACM.

Consecutive patients with at least two episodes of AM and referred to a tertiary university referral center (pop. 1.500.000 inhabitants) for clinical expertise, follow-up and etiological work-out were prospectively included in this registry.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with at least two episodes of acute myocarditis as defined by the European Society of Cardiology diagnostic criteria.

排除标准

  • 未提供

结局指标

主要结局

Sustained ventricular arrhythmia

时间窗: 0 - 1 year after last acute myocarditis episode

Any ventricular arrhythmia (VT/VF) : * sustained (lasting more than 30 seconds) * symptomatic or not (including sudden cardiac arrest) * induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)

Genetic mutation

时间窗: 0 - 1 year after last acute myocarditis episode

Any genetic mutation (cardiomyopathy panel)

次要结局

  • Myocardial substrate characterization(0 - 1 year after last acute myocarditis episode)
  • Nonsustained ventricular arrhythmia(0 - 1 year after last acute myocarditis episode)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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