DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death (ANDROMEDA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Number of differentially methylated genes as assessed by EPIC microarray
研究概览
简要总结
The goal of this observational study is to evaluate if there are differences in DNA methylation of peripheral blood in patients with Brugada syndrome and healthy subjects. The main question it aims to answer is:
Does DNA methylation changes distinguish Brugada patients from healthy controls?
Does DNA methylation changes distinguish Brugada patients with high versus low risk of sudden cardiac death?
详细描述
The Investigators will enroll 10 patients with Brugada syndrome and 10 age and sex matched healthy controls. We will collect 5 mL of peripheral blood and will analyze genome-wide DNA methylation via EPIC array platform. Bioinformatic algorithms and network analysis will be applied to identify possible diagnostic and predictive biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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 was confirmed when the 12-lead ECG showed ST-segment elevation with a type-1 morphology of ≥2 mm in ≥1 right precordial lead either spontaneously or after a provocative drug test (intravenous administration of a Class I antiarrhythmic) in the absence of any structural heart disease.
- •>18 years
- •Unrelated patients
排除标准
- •Related patients
- •Not type 1 Br patter
结局指标
主要结局
Number of differentially methylated genes as assessed by EPIC microarray
时间窗: 3 months
We will compare the methylation profiles of patients and controls in order to obtain a panel of differentially methylated genes.
次要结局
- Diagnostic performance of differentially methylated regions predicting the risk of sudden cardiac death(6 months)
研究者
Giuditta Benincasa
Principal Investigator
University of Campania Luigi Vanvitelli