Efficacy of a Myocardial Panel (Virological, Bacterial and Autoimmune) in the Management and Treatment of Pediatric Myocarditis Complicated With Arrhythmias or Ventricular Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Arrhythmias duration
研究概览
简要总结
The goal of this observational study is to determine the efficacy a of combined management and treatment driven by the systematic determination of viral genome, bacterial serology, and markers of inflammation in pediatric patients (< 18 years old) diagnosed with myocarditis complicated by arrhythmias (supraventricular and ventricular tachycardias and heart block) or ventricular dysfunction (left ventricular ejection fraction < 50% or right ventricular fractional area change < 35%).
The main question it aims to answer is: Does this panel help resolve arrhythmias or myocardial dysfunction due to myocarditis during hospitalisation and follow-up?
Researchers will compare patients managed and treated in 2024 without applying the myocarditis panel with those enrolled in 2025 who received the panel. Arrhythmias and myocardial dysfunction will be managed in accordance with recent guidelines. Antiviral, antibiotic or immunosuppressive therapies will be implemented in addition to standard therapy when required by the panel.
详细描述
The Investigators will enrol consecutive pediatric patients (< 18 years old) presenting with myocarditis complicated by arrhythmias or ventricular dysfunction.
The participants will undergo routine daily visits and electrocardiographic and echocardiographic assessment during hospitalisation (within 8 weeks).
During follow-up, a routine visit including an echocardiogram, ECG, and blood tests (complete blood count, liver function tests, renal function tests, inflammation indices, and myocardial necrosis tests) will be performed within the first 40 days of discharge; thereafter, every 3 months after discharge for a total of 6 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the consecutive pediatric patients (< 18 years old) presenting with myocarditis complicated by arrhythmias or myocardial dysfunction
排除标准
- •Refused consent to be included in the study given by parents or legal tutors
- •Uncomplicated myocarditis presenting without arrhythmias or myocardial dysfunction
结局指标
主要结局
Arrhythmias duration
时间窗: From enrollment to the end of the hospitalisation (maximum of 8 weeks)
Total duration of in-hospital arrhythmias assessed by electrocardiography
Myocardial dysfunction
时间窗: From enrollment to the end of the hospitalisation (maximum of 8 weeks)
Total duration of myocardial dysfunction assessed by echocardiography
次要结局
- Follow-up(6 months)
研究者
Francesco Bianco
Principal investigator
Azienda Ospedaliero, Universitaria Ospedali Riuniti