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临床试验/NCT07043166
NCT07043166招募中不适用

Epidemiological Survey and Follow-up of Cardiovascular-Kidney-Metabolic Diseases Among Adults in Shanghai

Shanghai Changzheng Hospital1 个研究点 分布在 1 个国家目标入组 4,094 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,094
试验地点
1
主要终点
Number of Participants Who developed cardiovascular diseases.

研究概览

简要总结

The main purpose of this study is to conduct follow-up assessments and update the cardiorenal outcomes among the STONE cohort that was established during 2016-2017. The secondary aim is to compare metabolic risk factors, metabolic disturbances, and clinically relevant metabolic outcomes between the follow-up period and the baseline assessment. The exploratory goal is to examine the relationships between changes in risk factors and clinical outcomes in the participants.

The study is planned to begin in May 2025 and will finalize the data collection for the entire population by June 2026. During this time, participants will be categorized based on CKM staging. The follow-up phase will continue until 2035.

详细描述

Between 2016 and 2017, Shanghai Changzheng Hospital conducted a random stratified sampling in 10 communities in Shanghai among individuals aged 18-65 years who had resided in the community for more than six months. Pregnant women, individuals with fractures, severe mental disorders or dementia, bedridden individuals, and those with hepatitis, tuberculosis, AIDS, other infectious diseases, severe liver or kidney dysfunction, and other serious life-threatening diseases were excluded. The Shanghai Thyroid autOimmuNity: an Epidemiological research (STONE) cohort was established. Trained physicians collected multidimensional baseline health data from more than 4,000 Shanghai community residents through questionnaires, structured interviews, physical examinations, and clinical tests. The data included demographic information (gender, age, education level, marital status, employment status, income level, etc.), lifestyle and psychological status (smoking history, alcohol consumption history, dietary habits, sleep, physical activity, etc.), physical examination indicators (height, weight, waist circumference, blood pressure), comprehensive metabolic indicators (complete blood count, liver and kidney function, thyroid function, glucose metabolism indicators, lipid metabolism indicators, tumor immunity, hormone levels), and ultrasound imaging data (abdominal ultrasound, thyroid ultrasound, carotid ultrasound, bone density).

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

  • The 4,094 residents of Shanghai communities who have been enrolled in the STONE cohort.
  • Individuals who completed the baseline questionnaire survey, physical examination, and related clinical tests between 2016 and 2017, with complete data records.
  • Willingness to participate in this follow-up study and provision of informed consent.

排除标准

  • Participants who have moved away from their original community and have been living elsewhere for more than two years.
  • Participants whose contact information has changed or become invalid, resulting in loss of contact (those who remain uncontactable after three attempts to reach out).

结局指标

主要结局

Number of Participants Who developed cardiovascular diseases.

时间窗: Through study completion, an average of 10 year

The diagnosis of cardiovascular diseases should be made according to the outcomes of carotid ultrasound and cardiac biomarkers.

次要结局

  • Number of Participants Who developed metabolic disorders.(Through study completion, an average of 10 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuo Li, MD

Deputy Director

Shanghai Changzheng Hospital

研究点 (1)

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