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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 : September 14, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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
Healthy

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 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 : January 2, 2000
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort
PROOF cohort
Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date.



Primary Outcome Measures :
  1. Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ]

Secondary Outcome Measures :
  1. Presence and severity of clinically silent stroke revealed through brain MRI [ Time Frame: Years 1, 3 and 5 ]
  2. Neuropsychological performance [ Time Frame: Years 1, 3 and 5 ]
  3. ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability [ Time Frame: Years 1, 3 and 5 ]
  4. Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP [ Time Frame: Years 1, 3 and 5 ]

Biospecimen Retention:   Samples With DNA
Serum, DNA


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Ages Eligible for Study:   65 Years to 65 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects were recruited amongst the inhabitants of the city of Saint-Etienne, France, and were eligible if aged 65 at the inclusion date.
Criteria

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

Information from the National Library of Medicine

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


Locations
France
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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00759304     History of Changes
Other Study ID Numbers: 9808112
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Aging
cardiovascular risk factors
Autonomic nervous system
stroke
Myocardiac infarction
Neuropsychological evaluation
Prospective cohort