Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years old informed consent signed Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PROOF cohort<br>Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events |  | During all the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, cardiovascular risk factors, Autonomic nervous system, stroke, Myocardiac infarction, Neuropsychological evaluation, Prospective cohort