Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,011
- 试验地点
- 1
- 主要终点
- Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events
研究概览
简要总结
The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.
Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population.
This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired population, but should these levels decline overtime, to use this as a predictor of cardiovascular and cerebrovascular events, taking into account established cardiovascular risk factors.
详细描述
The main goal of this PROOF study is to evaluate, on a selected prospective cohort of subjects aged 65 years upon study entry, the prognostic values of ANS activity levels measured at preset times, and more specifically, of its decline over the follow-up period, for fatal and non-fatal cardiovascular and cerebrovascular 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
- 65 Years 至 65 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years old
- •informed consent signed
排除标准
- •prior myocardiac infarction
- •prior stroke
- •hearth failure
- •atrial fibrillation
- •insulin-treated diabetes mellitus
- •cardiac pacemaker
- •disease limiting life expectancy to < 5 years
- •contraindication to brain MRI
- •living in an institution
结局指标
主要结局
Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events
时间窗: During all the study
次要结局
- Presence and severity of clinically silent stroke revealed through brain MRI(Years 1, 3 and 5)
- Neuropsychological performance(Years 1, 3 and 5)
- ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability(Years 1, 3 and 5)
- Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP(Years 1, 3 and 5)