跳至主要内容
临床试验/NCT04149600
NCT04149600进行中(未招募)不适用

Identification of Genetic Causes of Calcific Aortic Valve Disease

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
2
主要终点
Identification of expression signatures of aortic valve development and calcification in the macroscopically normal and abnormal portions of aortic valves excised during aortic valve replacement.

研究概览

简要总结

This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery

排除标准

  • Age < 20 years
  • Unable/unwilling to consent
  • History of aortic valve replacement or transcatheter aortic valve replacement (TAVR)
  • History of endocarditis
  • History of rheumatic fever
  • History of chest radiotherapy
  • History of organ transplant

结局指标

主要结局

Identification of expression signatures of aortic valve development and calcification in the macroscopically normal and abnormal portions of aortic valves excised during aortic valve replacement.

时间窗: 8 years

We will take a portion of the aortic valve and/or aortic tissue that is routinely excised for aortic valve or aortic replacement for expression analyses and generation of fibroblast cell lines. In collaboration with the Department of Pathology, we have established methods to take sufficient "normal" and abnormal tissue while allowing formal routine pathological evaluation. All tissue samples for expression analysis will be transported in iced RNALater and later frozen in a -80°C research freezer, prior to next generation sequencing. We may use tissue samples to develop cell lines for indefinite use.

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

Simon Robson

Professor of Anaesthesia

Beth Israel Deaconess Medical Center

研究点 (2)

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