跳至主要内容
临床试验/NCT05283759
NCT05283759招募中不适用

UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 1992年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Ventricular arrhythmias

研究概览

简要总结

The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).

详细描述

The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.

These includes:

  1. demographical data: age, sex
  2. antropometric data: height, weight, BMI
  3. clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy
  1. data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Brugada syndrome diagnosis

排除标准

  • Other diagnosis different from Brugada syndrome

结局指标

主要结局

Ventricular arrhythmias

时间窗: through study completion, an average of 10 year

Composite of: sudden cardiac death, aborted sudden cardiac death, ventricular fibrillation, sustained ventricular tachycardia, ICD appropriate therapy

Atrial fibrillation

时间窗: through study completion, an average of 10 year

Atrial fibrillation occurrence

Cardiovascular death

时间窗: through study completion, an average of 10 year

Death for cardiovascular cause

Death for any cause

时间窗: through study completion, an average of 10 year

Death for any cause

Genetic mutations

时间窗: Baseline

Genetic mutations (pathogenic and variant of unknown significance) associated with Brugada syndrome. Wide gene panel with next generation sequencing will be used: Roche SeqCap® EZ Human Exome Probes v3.0 for BrS.

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

Carlo de Asmundis

Director of Heart Rhythm Management Center

Universitair Ziekenhuis Brussel

研究点 (1)

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UZ Brussel HRMC Registry of Brugada Syndrome | 临床试验