PROOF - Prospective evaluation of Autonomic Nervous System (ANS) as a prognostic indicator of cardiovascular and cerebrovascular event in a cohort
Head :
Barthélémy Jean-Claude, Laboratoire SNA-EPIS EA4607 (Système nerveux Autonome - Epidémiologie, Physiologie, Ingénierie, Santé)Service de Physiologie Clinique du CHU de St EtienneUniversité Jean Monnet - PRES Lyon
Roche Fredéric, Laboratoire SNA-EPIS EA4607 (Système nerveux Autonome - Epidémiologie, Physiologie, Ingénierie, Santé)Service de Physiologie Clinique du CHU de St EtienneUniversité Jean Monnet - PRES Lyon
Roche Fredéric, Laboratoire SNA-EPIS EA4607 (Système nerveux Autonome - Epidémiologie, Physiologie, Ingénierie, Santé)Service de Physiologie Clinique du CHU de St EtienneUniversité Jean Monnet - PRES Lyon
Last update : 02/07/2017 | Version : 4 | ID : 3650
| General | |
| Identification | |
| Detailed name | Prospective evaluation of Autonomic Nervous System (ANS) as a prognostic indicator of cardiovascular and cerebrovascular event in a cohort |
| Sign or acronym | PROOF |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL (15/11/2000) |
| General Aspects | |
| Medical area |
Cardiology Geriatrics Neurology |
| Health determinants |
Genetic |
| Keywords | autonomic nervous system (ANS), heart rate variability, baroreflex, blood pressure variability, Prevention, epidemiology, sleep |
| Scientific investigator(s) (Contact) | |
| Name of the director | Barthélémy |
| Surname | Jean-Claude |
| Address |
Physiologie CHU Nord - Etage 6 42055 Saint Etienne cedex 2 |
| Phone | +33 (0)4 77 82 83 00 |
| jc.barthelemy@univ-st-etienne.fr | |
| Unit | Laboratoire SNA-EPIS EA4607 (Système nerveux Autonome - Epidémiologie, Physiologie, Ingénierie, Santé)Service de Physiologie Clinique du CHU de St EtienneUniversité Jean Monnet - PRES Lyon |
| Organization | CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE |
| Name of the director | Roche |
| Surname | Fredéric |
| Address |
Physiologie CHU Nord - Etage 6 42055 Saint Etienne cedex 2 |
| Phone | +33 (0)4 77 82 83 00 |
| frederic.roche@univ-st-etienne.fr | |
| Unit | Laboratoire SNA-EPIS EA4607 (Système nerveux Autonome - Epidémiologie, Physiologie, Ingénierie, Santé)Service de Physiologie Clinique du CHU de St EtienneUniversité Jean Monnet - PRES Lyon |
| Organization | CENTRE HOSPITALIER UNIVERSITAIRE DE |
| Collaborations | |
| Details | Other related cohorts: 1) Also in charge of the analysis of the activity of ANS in the Sapaldia cohort (Swiss cohort study on air pollution and lung diseases in adults). 2) Aube cohort: ANS evolution after normal or premature birth and cognitive evolution. |
| Funding | |
| Funding status |
Mixed |
| Details | - PHRC National PROOF, 1999- PHRC National Synapse, 2022- PHRC Régional Telamons, 2003- Industrie pharmaceutique: Laboratoire Servier (Neuropsychologie)- Industrie, Ingenierie SNA: Société Novacor (Cifre)- Association Synapse: association créée par les sujets de l'étude pour soutenir le projet. - TGIR cohortes 2008 (INSERM) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU St Etienne |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | PRES de LYON |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Université Jean Monnet |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A population file |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Form the electoral list of the city of Saint. Etienne |
| Database objective | |
| Main objective |
Evaluate on a prospective basis the predictive value of ANS activity, and its decline during the follow-up, on the occurrence of serious cerebral events, and on mortality all cause considered, in a general population of homogeneous age, 65 at inclusion.
Secondary objectives have been defined, analyzing the association between ANS and: 1) The presence and severity of cerebrovascular accidents at NRM imaging; 2) Neuropsychological performances; 3) Classic cardiovascular risk factors; 4) Genetic of the specific receptors of the neurotransmitters directly implied; 5) Sleep respiratory pathologies; 6) Realization of temporal analysis to determine chronological sequences of the decline of ANS activity and pathological conditions occurrence, including emerging conditions, such as sleep respiratory pathologies. |
| Inclusion criteria |
- 65 ages old subjects at inclusion, and registered on the electoral lists of the city of St.Etienne.
- Subjects who did not have a myocardial infarction or a preceding cerebrovascular accident. - Subjects not insulin-dependent |
| Population type | |
| Age |
Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Auvergne Rhône-Alpes |
| Detail of the geography area | City of Saint-Etienne |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2001 |
| Date of last collection (YYYY or MM/YYYY) | 01/2015 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1011 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at inclusion and every 2 years during the follow-up. Information collected through the clinical examination: 1) School data 2) Neuropsychological check: - Grober and Buschke; - Benton; - Digit substitution st; - Baddeley's dual task; -Trail marking test; - Stroop; - Wais; - MMSE; 3) Depression (QD2A) 4) Anxiety (Goldberg) 5) Sleep: St. Mary's hospital questionnaire 6) Sleep: Pittsburg questionnaire |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | Clinical examination at inclusion and every 2 years during the follow-up. Information collected through the clinical examination: 1) School data 2) Neuropsychological check: - Grober and Buschke; - Benton; - Digit substitution st; - Baddeley's dual task; -Trail marking test; - Stroop; - Wais; - MMSE; 3) Depression (QD2A) 4) Anxiety (Goldberg) 5) Sleep: St. Mary's hospital questionnaire 6) Sleep: Pittsburg questionnaire |
| Paraclinical data (detail) | Cerebral MRI with a visual evaluation and a quantity analysis (cerebral morphometry for three-dimensional reconstruction), polysomnography functional respiratory exploration, measure of muscular and fat mass, quantitative computed tomography |
| Biological data (detail) | Blood biology: classic cardiovascular risk factors, inflammation markers, hormones, vitamin D |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum DNA |
| Details of biobank content | Seurm bank, DNA bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Others |
| Other (detail) | Sleep quality, biological inflammatory and hormonal check, genetic check |
| Procedures | |
| Data collection method | Data have been collected during 5 check-ups, check-ups 1 and 4 are completed, check-ups 2, 3 and 5 are partials (neither cerebral NRM nor neuropsychological check).Clinical data collected concern: - Neuropsychological check analyzing memory, executive and dysexecutive functions (GROBER, BENTON, DSST, BADDELEY, TMT, STROOP, FLUENCIES, WAIS, MMSE)- Depression (QD2A)- Anxiety (GOLDBERG)- Ambulatory blood pressure monitoring, MAPA- HOLTER ECG- Elasticity of arterial walls- Baroreflex- Genetic check- Questionnaire on the existence and severity of restless legs syndrome- Sleep quality questionnaire: St. Mary’s hospital and PittsburgSelf-questionnaire data concern:- Evaluation of daily physical activity- Sleep quality (BERLIN, EPWORTH)- Life quality- Urinary disorders (DITROVIE, MHU)Data collected through the interview concern family and personal history (age of menopause, cardiovascular history, personal history, family history, treatments in progress, weight, height, waist/hips circumference, stature, tobacco, alcohol habitudes) |
| Classifications used | Coherence request after computer data entry. Missing data checked back to the original file or asked back to the patient or a third. Doctors and Subjects remainders for follow-up visits. Internal and external quality audit reports. Internal audit frequency: Statistics, by data themes. External audit frequency: 3. Patients receive information about the use of their data. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 15 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-Cohorte-PROOF |
| Description | List of publications in Pubmed |
| Link to the document | Proof_Liste_from EndNote.doc |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Submit a demand to the director of the SNA-EPIS team. Decision by the steering committee. Data utilization possible for academic teams. Contractual access condition: contact the main investigator or a co-investigator. Data utilization available for industrials. Access condition: contact the main investigator. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
