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