PRESSTO - PRogestogens, EStrogens and STrOke

Head :
Pierre-Yves Scarabin
Canonico Marianne, Équipe Hormones et Maladies Cardiovasculaires UMR-S 1018

Last update : 06/12/2014 | Version : 1 | ID : 5554

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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 PRogestogens, EStrogens and STrOke
Sign or acronym PRESSTO
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CCTIRS n°11.208 et CNIL n°DR-2011-473
General Aspects
Medical area Cardiology
Neurology
Others (details) Stroke (cerebrovascular accident)
Keywords Hormone therapy for menopause, oestrogen, progestin
Scientific investigator(s) (Contact)
Name of the director Pierre-Yves
Surname Scarabin
Address 16 Avenue Paul Vaillant Couturier, 94807 VILLEJUIF
Phone +33 (0)1 45 59 51 12
Email pierre-yves.scarabin@inserm.fr
Organization Institut National de la Santé et de la Recherche
Name of the director Canonico
Surname Marianne
Address 16 Avenue Paul Vaillant Couturier, 94807 VILLEJUIF
Phone +33 (0)1 45 59 51 66
Email marianne.canonico@inserm.fr
Unit Équipe Hormones et Maladies Cardiovasculaires UMR-S 1018
Organization Institut National de la Santé et de la Recherche
Collaborations
Funding
Funding status Public
Details IReSP
Governance of the database
Sponsor(s) or organisation(s) responsible Institut National de la Santé et de la Recherche Médicale
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Case control study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Hospital cases are identified by PMSI data (codes corresponding to primary or associated diagnosis). Women considered to be in good health are randomly selected from the original cohort as controls and matched with cases according to age and place of residence (4 controls per case).
Database objective
Main objective To evaluate the risk of cardiovascular disease (cerebrovascular accident, myocardial infarction and pulmonary embolism) in connection with hormone therapy for menopause while considering the administration route for oestrogen and types of progestin.
Inclusion criteria - Women - between 50 and 70 years old - menopausal
Population type
Age Adulthood (45 to 64 years)
Population covered General population
Gender Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2009
Size of the database
Size of the database (number of individuals) Greater than 20 000 individuals
Details of the number of individuals 100000 - 20000 cas / case - 80000 témoins / controls
Data
Database activity Data collection completed
Type of data collected Clinical data
Administrative data
Clinical data (detail) Direct physical measures
Medical registration
Administrative data (detail) INSEE commune code
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Care consumption (detail) Medical/paramedical consultation
Medicines consumption
Procedures
Participant monitoring No
Links to administrative sources Yes
Linked administrative sources (detail) Basic health insurance (SNIIR-AM)
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Anonymised data is transmitted as an encrypted file whose decryption key is generated by the coordinator. Only those involved in the project have access to data and are under the responsibility of the coordinator.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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