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临床试验/NCT05435898
NCT05435898尚未招募不适用

Comprehensive Assessment and Digital-health Based Intervention on Early-stage Cardiovascular Organ Damage and Cardiovascular Risk in Chinese: An All-comer Registry Study

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
4,000
试验地点
1
主要终点
composite endpoint of cardiovascular events

研究概览

简要总结

To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events.

To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events.

详细描述

In this project, we will register outpatients with cardiovascular diseases and healthy subjects for cardiovascular health check-up in the cardiovascular research clinic of our hospital, comprehensively evaluate their cardiovascular risk factors, subclinical organ damage and cardiovascular diseases at baseline. For participants who is willing to go further, a digital-based intervention will be provided for them to improve their knowledge and behaviour on cardiovascular health. For all participants, their status on subclinical organ damage, cardiovascular diseases and events will be followed within five years. The primary outcome is the composite endpoints of cardiovascular adverse events including acute coronary syndrome, myocardial infarction, heart failure, cardiovascular death. The secondary outcomes include individual cardiovascular adverse events, all-cause mortality, subclinical organ damage including cardiac damage (left ventricular hypertrophy and diastolic dysfunction), renal damage (chronic kidney disease, microalbuminuria), and vascular damage (arterial stiffness, plaques, intima-median thickening, retina arteriosclerosis). By doing these, we will be able to build a registry study and to reveal the epidemiology of subclinical organ damage, validate the association between subclinical organ damage and cardiovascular events in Chinese, and explore the significance of digital-based intervention in the prevention from subclinical organ damage and cardiovascular diseases and events.

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

入选标准

  • aged 18 years or older
  • willing to participate the study and sign informed consent
  • available for long-term follow-up

排除标准

  • severe heart disease (NYHA IV)
  • stage 4 or 5 CKD
  • malignant tumors or with life expectancy less than 5 years
  • stroke within 3 months
  • refuse to participate the study or not available for long-term follow up

结局指标

主要结局

composite endpoint of cardiovascular events

时间窗: 5 years

rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death

次要结局

  • Individual cardiovascular events(5 years)
  • all cause mortality(5 years)
  • New on-set subclinical organ damage(5 years)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Wei Xu

Director of Cardiac Center

Shanghai 10th People's Hospital

研究点 (1)

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