ITMO public health
Last update : 01/01/2019 | Version : 4 | ID : 187
| General | |
| Identification | |
| Detailed name | Management of high cardiovascular risk patients treated with statins in France |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL approval : 770334 - 8 November 2007 |
| General Aspects | |
| Medical area |
Cardiology |
| Keywords | statins, rosuvastatin, cardiovascular risk factors |
| Scientific investigator(s) (Contact) | |
| Name of the director | Piedbois |
| Surname | Pascal |
| Address |
3, rue de la Porte de l’hôpital 67065 Strasbourg Cedex, France |
| Phone | +33-388252401 |
| ppiedbois@strasbourg.unicancer.fr | |
| Organization | Centre Paul Strauss |
| Name of the director | Thomas-Delecourt |
| Surname | Florence |
| Phone | +33 (0)1 1 29 40 25 |
| florence.thomas@astrazeneca.com | |
| Unit | AstraZeneca |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | AstraZeneca |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | ASTRAZENECA |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | The physicians participating in the study recruit the subjects to be included among the patients that they see in consultation and according to the inclusion criteria |
| Database objective | |
| Main objective | To describe utilisation of newly prescribed statins in French primary care |
| Inclusion criteria | Any patient for whom a treatment with statin was initiated for at least 3 months and less than 6 months |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2100 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data Administrative data |
| Clinical data (detail) |
Medical registration |
| Biological data (detail) | * Existence of one or more lipid levels and results since the beginning of the treatment* Other biological dosages since the beginning of the treatment: Transaminases, CPK |
| Administrative data (detail) | Age, gender |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publication ESC 2010 congress poster |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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