Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events (PROOF)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years|
- Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ] [ Designated as safety issue: No ]
- Presence and severity of clinically silent stroke revealed through brain MRI [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]
- Neuropsychological performance [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]
- ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]
- Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP [ Time Frame: Years 1, 3 and 5 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759304
|Centre Hospitalier de Saint-Etienne|
|Saint-Etienne, France, 42055|
|Principal Investigator:||Jean-Claude BARTHELEMY, MD PhD||CHU de Saint-Etienne|