Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events (PROOF)

Centre Hospitalier Universitaire de Saint Etienne

Status: Active, not recruiting

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT00759304

9808112

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,011 patients

Sex: All

Ages: 65 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,011 participants in 1 patient group

PROOF cohort

Description:

Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date.