Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00759304
First received: September 24, 2008
Last updated: February 26, 2014
Last verified: February 2014

September 24, 2008
February 26, 2014
January 2001
December 2015   (final data collection date for primary outcome measure)
Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00759304 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events
Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, DNA

Non-Probability Sample

Subjects were recruited amongst the inhabitants of the city of Saint-Etienne, France, and were eligible if aged 65 at the inclusion date.

Healthy
Not Provided
PROOF cohort
Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1011
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
65 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00759304
9808112
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Jean-Claude BARTHELEMY, MD PhD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP