NCT03842592进行中（未招募）不适用
Quantification of Ventricular Arrhythmia After Myocarditis in Sportsman
University Hospital, Angers8 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年11月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Complex ventricular arrhythmia
研究概览
简要总结
The study aims to assess the prevalence of ventricular rhythmic disorder after an acute myocarditis in sportsmen.
50 patients with acute myocarditis, confirmed by MRI, will be assessed by ECG Holter and Treadmill stress test during a 1-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myocarditis, diagnosed on the association of (a) recent viral infection (upper airway, gastro-intestinal) , (b) troponin increase, and (c) chest pain AND myocarditis confirmed by cardiac magnetic resonance 2 out of 3 Lake Louise criteria, either T2 hypersignal, early enhancement or late gadolinium enhancement.
- •regular physical activity, recreational or competitive: >=4 hours weekly
- •written informed consent
排除标准
- •coronary artery disease
- •acute inflammatory cardiomyopathy (sarcoidosis, fulminant myocarditis, Tako Tsubo, eosinophilic myocarditis, Lyme disease)
- •history of myocarditis
- •contra-indication to cardiac MRI
- •patient unable to perform a treadmill stress test
研究组 & 干预措施
To establish the rhythmic load of sports patients at a distance from a first episode of myocarditis.
Other
Stress testing and 24-hour Holter ECG are the tools currently recommended for assessing rhythmic load and, consequently rhythmic risk. These investigations will be perform at 1 years after myocardite.
干预措施: Treadmill Stress test (Diagnostic Test)
结局指标
主要结局
Complex ventricular arrhythmia
时间窗: any timepoint: 3 month and/or 1 year
any ventricular tachycardia (triplet or more), ventricular fibrillation (observed on ECG Holter or during stress test)
次要结局
- In-hospital ventricular arrhythmia(up to 2 weeks after admission)
- Major adverse cardio vascular event(up to 2 years after inclusion)
- Left ventricular fibrosis(between baseline and 3 months)
- Left Ventricular remodeling(between baseline and 3 months)
- return to physical activity(up to 2 years after inclusion)
研究者
研究点 (8)
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