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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00759304
Collaborator
Ministry of Health, France (Other)
1,011
Enrollment
1
Location
323
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1011 participants
    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
    Actual Study Start Date :
    Jan 2, 2000
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    PROOF cohort

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

    Outcome Measures

    Primary Outcome Measures

    1. Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [During all the study]

    Secondary Outcome Measures

    1. Presence and severity of clinically silent stroke revealed through brain MRI [Years 1, 3 and 5]

    2. Neuropsychological performance [Years 1, 3 and 5]

    3. ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability [Years 1, 3 and 5]

    4. Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP [Years 1, 3 and 5]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier de Saint-Etienne Saint-Etienne France 42055

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Saint Etienne
    • Ministry of Health, France

    Investigators

    • Principal Investigator: Jean-Claude BARTHELEMY, MD PhD, CHU de Saint-Etienne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Centre Hospitalier Universitaire de Saint Etienne
    ClinicalTrials.gov Identifier:
    NCT00759304
    Other Study ID Numbers:
    • 9808112
    First Posted:
    Sep 25, 2008
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
    Aging
    cardiovascular risk factors
    Autonomic nervous system
    stroke
    Myocardiac infarction
    Neuropsychological evaluation
    Prospective cohort

    Study Results

    No Results Posted as of Apr 6, 2022