Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 主要终点
- Identification of a dysrhythmia
研究概览
简要总结
Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm disturbances could emerge only during seizures. Furthermore, patients could have transitioned sinus or AV node blocks which could cause syncopes with brady-related seizures which could be treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording single-channel ECG for up to 36 months which give an ability to detect these heart disturbances.
The purpose of this study is to look the incidence and types of arrhythmias which occur in 150 patients with hard-to-treat partial seizures and secondarily generalized seizures
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hard-to-treat focal epilepsy
- •Aged 18 to 60 years
- •If female not pregnant
排除标准
- •Known clinical relevant structural cardiac disease
- •Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
- •Use of beta blockers or other antiarrhythmic medication
- •Diagnosis of psychogenic non-epileptic seizures
结局指标
主要结局
Identification of a dysrhythmia
时间窗: 3 years or until the end-of-battery life of Reveal XT, whichever came first
A dysrhythmia will be defined as either * asystole of ≥6 s * sinus bradycardia of ≤40 bpm during physical activity * 2nd or 3rd-degree AV-block * sinus tachycardia of ≥120 bpm * nonsustained and sustained monomorphic VT of ≥170 bpm * polymorphic VT * atrial fibrillation/flutter
次要结局
- The number of patients who will have receive the permanent pacemaker at the end of the study.(3 years or until the end-of-battery life of Reveal XT, whichever came first)