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临床试验/NCT03955432
NCT03955432终止不适用

Long-term Cardiac Monitoring in Epilepsy: Comparative Group Study to Assess Risk of Interictal and Ictal Cardiac Dysfunction

Northwell Health1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
1
主要终点
Incidence rate of an event (i.e., arrhythmia or seizure)

研究概览

简要总结

The purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Patients with epilepsy have a higher risk for cardiac complications than the general population. With this study, we aim to understand more about these potential complications in patients with epilepsy and assess if treatments for cardiac problems should be evaluated more carefully in patients with epilepsy.

详细描述

Most cardiac studies have investigated patients with intractable focal epilepsy who have a high risk for co-morbidities, accidents, injury and SUDEP. This is confounded by the major antiepileptic drug burden in this population. Very little, however, is known about the risk of cardiac arrhythmias in patients with a lower seizure burden, i.e. patients with infrequent focal seizures and/or those without secondarily generalized convulsions. Furthermore, no chronic cardiac data is available in patients with epileptic encephalopathies especially given the fact that some of these patients are known to carry mutations that increase the risk for cardiac arrhythmias.In addition, periods of reduced cerebral blood flow during tachy or brady arrhythmias may exacerbate seizure severity and during. Diagnosing and treating these arrhythmias may not only prevent adverse cardiac events, but also reduce seizure burden. This study primarily aims to compare the frequency of cardiac rhythm abnormalities in patients with epilepsy of different severity, assess the long-term cardiac risk and evaluate the possible preventive role of anti-arrhythmic agents and/or cardiac pacemaker/defibrillator needs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-50 years with ability to consent.
  • No primary cardiac abnormality.
  • Ability to receive an implantable loop recorder and tolerate the procedure.
  • Patients with epilepsy as described by the three groups (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy)

排除标准

  • Cardiac disease of any type
  • Known epilepsy genetic disorder with potential cardiac compromise
  • Major co-morbidities such as cancer, diabetes, stroke, bleeding disorder
  • Chronic psychosis
  • Severe MR without reliable caregiver monitoring (what is MR?)
  • Already included in another clinical trial that will affect the objectives of this study.
  • Life expectancy is less than 1 year

结局指标

主要结局

Incidence rate of an event (i.e., arrhythmia or seizure)

时间窗: During the two years of monitoring

Ratio of the total number of observed events divided by the number of person-days at risk in that group. Arrhythmias will be classified into different categories based on the observed data. "Arrhythmia of any type", as well as specific categories of arrhythmias will be analyzed separately.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruben Kuzniecky

Vice Chairperson, Neurology

Northwell Health

研究点 (1)

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Long-term Cardiac Monitoring in Epilepsy | 临床试验