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临床试验/NCT05041296
NCT05041296招募中不适用

The Epileptic Heart - Multiparametric Cardiac Magnetic Resonance Imaging for Detection and Quantification of Acute and Chronic Cardiac Involvement in Patients With Epilepsy

University Hospital, Bonn2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
T1 relaxation time

研究概览

简要总结

The aim of the study is to use multiparametric cardiac MRI to identify any abnormalities in myocardial structure and function in patients with epilepsy. A two-stage study design is planned as part of the study:

  1. In the acute setting, cardiac MRI will be performed in patients before and after a tonic-clonic seizure and compared intraindividually. In this study arm, potential acute seizure-induced myocardial damage will be detected.
  2. In the chronic setting, cardiac MRI will be performed in patients with known chronic epilepsy during the seizure-free interval to detect potential chronic myocardial damage (myocardial fibrosis) and compared with a control population. Within the group of epilepsy patients, possible associations with various epilepsy-specific characteristics (e.g., form, cause, onset, duration, and severity of epilepsy) will be investigated.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

T1 relaxation time

时间窗: Measurement will be performed within 2 weeks after MRI scan.

T1 relaxation times will be obtained to asses acute myocardial injury and fibrosis. T1 maps will be analyzed using a segmental approach by region of interest analysis. T1 relaxation times are given in \[ms\].

次要结局

  • T2 relaxation time(Measurement will be performed within 2 weeks after MRI scan.)
  • Extracellular volume fraction(Measurement will be performed within 2 weeks after MRI scan.)
  • Myocardial strain(Measurement will be performed within 2 weeks after MRI scan.)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julian Alexander Luetkens

Principal Investigator, Senior Physician

University Hospital, Bonn

研究点 (2)

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