PRESSTO - PRogestogens, EStrogens and STrOke
Head :
Pierre-Yves Scarabin
Canonico Marianne, Équipe Hormones et Maladies Cardiovasculaires UMR-S 1018
Canonico Marianne, Équipe Hormones et Maladies Cardiovasculaires UMR-S 1018
Last update : 06/12/2014 | Version : 1 | ID : 5554
| 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 |
| 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 |
| 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 |
