EPP III - EPPIII - Cardiac rhythm, baroreflex and cardiovascular morbi-mortality on general population. The Paris Prospective Study III

Head :
Empana Jean-Philippe, U 970 INSERM
Jouven , U970 PARIS Descartes

Last update : 11/29/2019 | Version : 3 | ID : 60095

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name EPPIII - Cardiac rhythm, baroreflex and cardiovascular morbi-mortality on general population. The Paris Prospective Study III
Sign or acronym EPP III
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation PROMOTION INSERM N°C07-39/ N° CNIL 1255838
General Aspects
Medical area Cardiology
Study in connection with Covid-19 No
Pathology (details) Plasmatic biomarkers
Health determinants Genetic
Lifestyle and behavior
Medicine
Nutrition
Occupation
Social and psychosocial factors
Keywords observational cohort, cardiovascular disease, sudden cardiac death, blood biomarkers, carotid rigidity, echotracking, epidemiology
Scientific investigator(s) (Contact)
Name of the director Empana
Surname Jean-Philippe
Address 75015 PARIS
Phone +33 (0)1 53 98 80 20
Email jean-philippe.empana@inserm.fr
Unit U 970 INSERM
Organization INSERM - Institut National de Santé et Recherche
Name of the director Jouven
Address 75015 PARIS
Phone + 33 (0)1 56 09 36 87
Email xavier.jouven@egp.aphp.fr
Unit U970 PARIS Descartes
Organization INSERM-APHP
Collaborations
Participation in projects, networks and consortia Yes
Details The Reference Values for Arterial Measurements Collaboration
Others Other related cohorts: Constances cohort which will be supported by several French centers, including the Paris one
Funding
Funding status Public
Details ANR, DGS,IRESP,DIM CARDIOVASCULAIRE (GROS MATÉRIEL)
Governance of the database
Sponsor(s) or organisation(s) responsible INSERM - Institut National de Santé et Recherche Médicale
Organisation status Public
Presence of scientific or steering committees Yes
Additional contact
Name of the contact Perier
Surname Marie
Address INSERM U970 56 Rue Leblanc 75015 Paris
Email marie-cecile.perier@inserm.fr
Unit U970
Organization INSERM
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
A population file
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Prospective. Other organizations actives in the cohort constitution: Paris preventive and clinical investigation center. Inclusions completed in May 31th 2012
Database objective
Main objective Cross sectional analysis:
1) associations between baroreflex sensitivity and cardiac rhythm
2) determinants of the carotid stiffness and rigidity parameters as measured by echotracking.
Longitudinal analysis :
1) Cardiac rhythm and CV morbi-mortality
2) Baroreflex sensibility and CV morbi-mortality
3) Arterial stiffness and CV morbi-mortality
4) Biomarkers and CV morbi-mortality
Inclusion criteria Men and women between 50 and 75 years old, having a French general Social Security regime and consulting for an health check at the Paris preventive and clinical investigation center, voluntaries for the study (written consent), understanding French and accepting genetic analysis.
Population type
Age Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered General population
Pathology
Gender Male
Woman
Geography area Local
French regions covered by the database Île-de-France
Detail of the geography area Paris
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 06/2008
Date of last collection (YYYY or MM/YYYY) 05/2012 (inclusion completed)
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 10166
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Administrative data
Clinical data (detail) Direct physical measures
Medical registration
Details of collected clinical data Clinical examination at inclusion. Information collected during clinical examination : anthropometric records, blood pressure, dental, eye and gynecological examination… Continuous cardiac rhythm recording, study of the carotid vascular wall (echography) and carotid tracking echography (baroreflex measure).
Declarative data (detail) Paper self-questionnaire
Face to face interview
Details of collected declarative data Clinical examination at inclusion. Information collected during clinical examination : anthropometric records, blood pressure, dental, eye and gynecological examination… Continuous cardiac rhythm recording, study of the carotid vascular wall (echography) and carotid tracking echography (baroreflex measure).
Paraclinical data (detail) Imaging, holter ECG (3H) tracking carotid echography
Biological data (detail) Samples : blood, DNA, urine
Presence of a biobank Yes
Contents of biobank Whole blood
Serum
Plasma
DNA
Details of biobank content Serum bank, plasma bank, DNA bank
Health parameters studied Health event/morbidity
Health event/mortality
Quality of life/health perception
Procedures
Data collection method Self-questionnaire: paper form Clinical exams: hand written step Biological exams: direct entry
Quality procedure(s) used Coherence request after computer data entry. Missing data asked back to the original file. Subjects remainders for follow-up visits. Quality audit realization: external audits every year. Other quality procedures: regular audit (once a month by Inserm). Patients are informed about the use of their data.
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the participant (mail, e-mail, telephone etc.)
Monitoring by contact with the referring doctor
Monitoring by crossing with a medical-administrative database
Details on monitoring of participants Follow-up duration : 10 years at least; self-reported health and health events (cardiovascular, cancer, mortality) by questionnaire subsequently validated by independent adjudication comittee
Followed pathology • - Death from any cause
IX - Diseases of the circulatory system
II - Neoplasms
Links to administrative sources Yes
Linked administrative sources (detail) CépiDC; SNIRAM and PMSI (to be done)
Promotion and access
Promotion
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=%28%28%22Study+III%22+OR+%22Study+3%22%29+AND+%22paris+prospective+study%22%29
Description List of publications in Pubmed
Link to the document EPP3-Publications list-Nov2019.pdf
Description Scientific publication list by Nov 28-2019
Access
Presence of document that lists variables and coding procedures Yes
Terms of data access (charter for data provision, format of data, availability delay) Possible data utilization by academic teams: access conditions provided by a written convention. Possible use for industrial sector: contractual access conditions. Steering committee contact : pps3.u970@inserm.fr or jean-philippe.empana@inserm.fr
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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