跳至主要内容
临床试验/NCT05656820
NCT05656820招募中不适用

Prospective Cohort Study on Imaging Genetics of Bicuspid Aortic Valve

Suzhou Municipal Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7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
200
试验地点
1
主要终点
Diameter of ascending aorta

研究概览

简要总结

The Chinese Bicuspid Aortic Valve (BAV) Ultrasound imaging cohort study is a Chinese BAV ultrasound imaging cohort study. At present, a retrospective study cohort involving more than 30 hospitals has been established. The prospective multi-center study of BAV is expected to include and follow up 200 outpatients and inpatients with BAV. The clinical, ultrasound imaging and treatment parameters of the patients are collected and the patients are followed up for 2 years. To analyze the prognostic characteristics of BAV patients and establish a Chinese BAV database. The primary endpoint was all-cause death, and the secondary endpoints were heart failure, angina, severe aortic stenosis, severe aortic insufficiency, ascending aortic diameter ≥50mm, and surgery (surgical and interventional). According to the different pathological types of aortic valve in different types of BAV, ultrasound imaging was used to evaluate the different forms of valvular leaflet lesions and prognosis. Finally, it provides a basis for the prognosis, treatment method, treatment timing and treatment plan selection of BAV patients, and lays a foundation for the mechanism study of BAV arterial lesions and the establishment of risk model for the prognosis of BAV patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Ultrasound or other imaging tests to diagnose patients with BAV

排除标准

  • Patients with TAV or/and have significant aortic valve calcification
  • Those deemed unsuitable for enrollment by clinicians (e.g., end-stage patients, mentally ill patients, non-cooperating patients, etc.)
  • Those who do not agree to be included

结局指标

主要结局

Diameter of ascending aorta

时间窗: baseline; once a year; through study completion.

Diameter of ascending aorta shall be taken using leading edge-to-leading edge convention at end diastole.

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

Mo Zhou

Attending physician

Suzhou Municipal Hospital

研究点 (1)

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