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临床试验/NCT02865798
NCT02865798Unknown不适用

Multicenter Prospective Cohort Study of Senile Hospitalized Patients With Valvular Heart Disease

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,000
试验地点
1
主要终点
all cause mortality

研究概览

简要总结

Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.

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

  • Hospitalized patients over 60 years old meet one of the following conditions.
  • moderate or above valvular heart disease as defined by echocardiography:
  • aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg,
  • aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
  • mitral stenosis, moderate or above, or valve area ≤2.0cm2,
  • mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
  • tricuspid stenosis, moderate or above, or valve area ≤1.0cm2,
  • tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2,
  • pulmonic stenosis, moderate or above, or maximal jet velocity >4m/sec,
  • pulmonic regurgitation, moderate or above,
  • or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
  • or diagnosis of endocarditis as assessed by Duke criteria.

排除标准

  • Patients cannot be followed up for any reasons.
  • Patients in critical condition may be die in the near future.
  • Patients have been enrolled in this study.

结局指标

主要结局

all cause mortality

时间窗: one year

次要结局

未报告次要终点

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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