跳至主要内容
临床试验/NCT04544527
NCT04544527招募中不适用

The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
MACE

研究概览

简要总结

In the previous cohort studies focused on diabetes in China, there were few studies on elderly patients with diabetes. The aim of this prospective cohort study was to investigate the prevalence, management and nutritional status of elderly diabetic patients aged ≥65 years in Shanghai and Suzhou communities, and record the occurrence of endpoint events.

详细描述

This is a multicenter, observational, prospective cohort study.We plan to collect the baseline information in three years, and follow up every two years for at least 10 years. The study will enroll 5000 elderly diabetic patients aged ≥65 years and be conducted in Shanghai and Suzhou. The primary outcomes include MACE(major adverse cardiovascular events) , all-cause mortality, and chronic complications of diabetes and so on.

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
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women aged 65-100 years old;
  • Patients who had been diagnosed with diabetes mellitus.

排除标准

  • Patients with psychiatric disorders or impaired cognitive function;
  • Patients who cannot or reject to sign the consent form.

结局指标

主要结局

MACE

时间窗: Up to 10 years

major adverse cardiovascular events,including the first occurrence of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.

all-cause mortality

时间窗: Up to 10 years

All-cause mortality was confrmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Xiangcheng Center for Disease Control and Prevention.

次要结局

  • chronic complications of diabetes(Up to 10 years)

研究者

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

研究点 (1)

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