跳至主要内容
临床试验/NCT02623907
NCT02623907Unknown不适用

Registry Study of Aortic Valve Diseases in Chinese Elderly

Shanghai Zhongshan Hospital0 个研究点目标入组 2,000 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
主要终点
Surgical or transcatheter aortic valve replacement

研究概览

简要总结

With the aging of Chinese population, degenerative valvular disease is becoming more and more frequent, which has brought a heavy burden to our society. Taking aortic stenosis (AS) as an example, the incidence of AS in population over the age of 65 are about 2%, and in population above the age of 85 can be amounted to 4-8%, in the Western country. Since the invention of transcatheter aortic valve replacement (TAVR),aortic valve disease (AVD),including AS and aortic regurgitation (AR), has attracted more and more attention. To date, there are few data about the prevalence of AVD in China. The characteristics and prognosis of AVD in China are still unknown. Therefore, the investigators design a prospective, observational cohort study to investigate characteristics, treatments and prognosis of AVD in Chinese elderly population. The results of the study will provide a basis for the future national health policy for prevention and treatment of AVD in the elderly.

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

入选标准

  • Severe AS or AR indicated by echocardiography ;
  • 60 years old or older.

排除标准

  • Having both Severe AR and Severe AS;
  • Having underwent surgical or transcatheter treatment for AVD;
  • Non-degenerative AVD.

结局指标

主要结局

Surgical or transcatheter aortic valve replacement

时间窗: 36 months

from date of enrollment until the date of surgical or transcatheter aortic valve replacement, whichever came first, up to 36 months

Cardiovascular (CV) death or hospitalization for heart failure (HF)

时间窗: 36 months

from date of enrollment until the date of first documented HF or date of death from any cause, whichever came first, up to 36 months

次要结局

  • Number of all-cause mortality(from date of enrollment until the date of death for any-cause, up to 36 months)
  • Number of patients developing major cardiovascular and cerebral events (MACCE)(36 moths)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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