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临床试验/NCT02810821
NCT02810821进行中(未招募)不适用

Association Between Serum Gonadal Hormone, Gonadotropin and Cardiovascular Events

Shandong Provincial Hospital1 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
8,000
试验地点
1
主要终点
Cardiovascular disease mortality

研究概览

简要总结

Deficiency in gonadal hormone has been considered to play a role in ageing related increased incidence of cardiovascular events. But the mechanism has not been fully elucidated. On the other hand, the dramatic increase in gonadotropin level didn't drew much attention when talking about the increased risk of cardiovascular disease during menopausal transition. This study aim to investigate the association between gonadal hormone, gonadotropin and long-term 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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female with intact uterus and at least one ovary
  • Aged of 18 to 75 years old;

排除标准

  • Pregnancy or lactation women;
  • Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome or other endocrinal and metabolic disorders that known to compromise hypothalamic-pituitary-gonadal function;
  • Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies;
  • Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health;
  • Obviously poor compliance.

结局指标

主要结局

Cardiovascular disease mortality

时间窗: Measured after 10 years of follow-up

Total deaths from cardiovascular disease over a given period of time

Rate of first cardiovascular disorder events

时间窗: Measured after 10 years of follow-up

Total incidence rate from cardiovascular disorder over a given period of time

All-cause mortality

时间窗: Measured after 10 years of follow-up

Total deaths from all causes over a given period of time

次要结局

  • Change in serum lipid levels(Measured at baseline, and every 2 years during the 10-year follow-up period)
  • Number of participants that diagnosed with metabolic syndrome(Measured at baseline, and every 2 years during the 10-year follow-up period)
  • Number of participants that diagnosed with non-alcoholic fatty liver disease(Measured at baseline, and every 2 years during the 10-year follow-up period)
  • Change in thickness of blood vessel wall(Measured at baseline, and every 2 years during the 10-year follow-up period)

研究者

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

Jia-jun Zhao

Professor

Shandong Provincial Hospital

研究点 (1)

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