Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events (PROOF)
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|ClinicalTrials.gov Identifier: NCT00759304|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2008
Last Update Posted : February 18, 2021
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1011 participants|
|Official Title:||Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years|
|Actual Study Start Date :||January 2, 2000|
|Estimated Primary Completion Date :||December 2026|
|Estimated Study Completion Date :||December 2026|
Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date.
- Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ]
- Presence and severity of clinically silent stroke revealed through brain MRI [ Time Frame: Years 1, 3 and 5 ]
- Neuropsychological performance [ Time Frame: Years 1, 3 and 5 ]
- ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability [ Time Frame: Years 1, 3 and 5 ]
- Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP [ Time Frame: Years 1, 3 and 5 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759304
|Centre Hospitalier de Saint-Etienne|
|Saint-Etienne, France, 42055|
|Principal Investigator:||Jean-Claude BARTHELEMY, MD PhD||CHU de Saint-Etienne|