Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Electrocardiographic changes
研究概览
简要总结
The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size.
详细描述
All consecutive patients with either spontaneous or ajmaline-induced BrS-ECG pattern will be screened. A total of 30 BrS patients and 30 normal age, sex and BSA matched normal controls will be selected and enrolled. Patients will perform cardiac magnetic resonance imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. BrS patients will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Brugada syndrome with either spontaneous or ajmaline- induced type 1 ECG pattern
- •Indication to ajmaline testing and programmed ventricular stimulation
- •Age > or equal to 18 years
- •Written informed consent
排除标准
- •Pregnancy
- •Contraindication to CMRI or to ajmaline
- •Live espectance < 12 months
研究组 & 干预措施
BrS Group
Ajmaline 17-(Chloroacetate) Monohydrochloride
干预措施: Ajmaline 17-(Chloroacetate) Monohydrochloride (Drug)
No BrS group
Ajmaline 17-(Chloroacetate) Monohydrochloride
干预措施: Ajmaline 17-(Chloroacetate) Monohydrochloride (Drug)
结局指标
主要结局
Electrocardiographic changes
时间窗: 1 day during Electrocardiography
Changes of PR, QRS, and QT parameters, before and after ajmaline in Brugada patients as compared with control subjects
MRI changes of left and right ventricular function
时间窗: 1day during MRI
MRI changes of left and right ventricular function before and after ajmaline in Brugada patients as compared with control subjects
CMR parameters changes of the right and left ventricle function
时间窗: 1 day during CMR
Changes of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls
Electrical substrate changes of the right ventricle
时间窗: 1 day after ICD implantation
electroanatomical epicardial mapping for substrate determination before and after ajmaline
次要结局
未报告次要终点
研究者
Carlo Pappone
Head of Arrhythmology Department
IRCCS Policlinico S. Donato