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临床试验/NCT03521739
NCT03521739Unknown不适用

A National Registry for the Association of Synchronous Four-limb Blood Pressure and Pulse Wave Velocity With Cardiovascular Events in China

Chinese Academy of Medical Sciences, Fuwai Hospital19 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100,000
试验地点
19
主要终点
Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)

研究概览

简要总结

A multicenter prospective registry planned to recruit more than 100 000 patients 50 years old and older was carried out in China. This primary purpose of this study was to evaluate the association of synchronous four-limb blood pressure and pulse wave velocity with cardiovascular events. The secondary purpose was to evaluate the incidence rate,prevalence rate, value of diagnosis for peripheral arterial occlusive disease, and to follow up the effects of revascularization on cardiovascular events.

详细描述

Although many studies with the correlation between synchronous four-limb blood pressure and pulse velocity measurement and cardiovascular outcomes have existed currently, the sample sizes are relatively small and the data on Chinese populations are lacking.Therefore, a multicenter prospective registry planned to recruit more than 100 000 patients aged 50 years old and older was carried out in China. This primary purpose of this study was to evaluate the association of synchronous four-limb blood pressure and pulse wave velocity with cardiovascular events in chinese populations. The secondary purpose was to evaluate the incidence rate,prevalence rate, value of diagnosis for peripheral arterial occlusive disease, and to follow up the effects of revascularization on cardiovascular 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
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 50 years old at the time of informed consent
  • Chinese populations in hospital, community and physical examination center

排除标准

  • Patients with lack of limb,malformation of limbs, severe limb trauma or infection.
  • Serious organic disease affecting the quality of life, such as tumors, massive cerebral infarction, uremia, and etc.

结局指标

主要结局

Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)

时间窗: From date of enrollment until the date of first documented cardiovascular events or date of death from any cause, whichever came first, assessed up to 12 months

次要结局

  • Incidence of death from any cause(Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented death from any cause, assessed up to 60 months)
  • Incidence of peripheral arterial disease(Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented four-limb peripheral arterial disease or date of death from any cause, whichever came first, assessed up to 60 months)
  • Incidence of limb gangrene(Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented gangrene caused by peripheral arterial disease or date of death from any cause,whichever came first, assessed up to 60 months)
  • Incidence of amputation(Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented amputation caused by peripheral arterial disease or date of death from any cause, whichever came first, assessed up to 60 months)
  • Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)(Measured at 6 months, 24 months and every 12 months thereafter from date of enrollment until the date of first documented cardiovascular events or date of death from any cause, whichever came first, assessed up to 60 months)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiongjing Jiang

Professor

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (19)

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