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:
- 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.
- 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
- 否
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
Julian Alexander Luetkens
Principal Investigator, Senior Physician
University Hospital, Bonn
研究点 (2)
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