ITMO public health
Last update : 01/01/2019 | Version : 1 | ID : 134
| General | |
| Identification | |
| Detailed name | A 6 month follow-up o study of hospitalised patients with cardiac failure with Preserved systolic function (PSF-HF) in cardiology, internal medecine et geriatry |
| Sign or acronym | I-SYPRES |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°908014 |
| General Aspects | |
| Medical area |
Cardiology |
| Others (details) | cardiac insufficiency |
| Keywords | Cardiac insufficiency, intact systolic function, Cardiology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Herrmann |
| Surname | Marie-Annick |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| marie-annick.herrmann@bms.com | |
| Unit | Bristol-Myers Squibb |
| Name of the director | Schmidely |
| Surname | Nathalie |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| nathalie.schmidely@bms.com | |
| Unit | Bristol-Myers Squibb |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Bristol-Myers Squibb sanofi-aventis |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Bristol-Myers Squibb (BMS) |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Sanofi Aventis |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | random sampling in clusters |
| Database objective | |
| Main objective | Determine the demographic characteristics and of the disease of patients hospitalized in the cardiology department for cardiac failure with intact systolic function |
| Inclusion criteria |
Register Portion: M/F >=18 years, hospitalized for confirmed acute cardiac failure on the clinical symptoms and signs, Study Portion: Patient in the register, diagnosed for HF-ISF with an EF >45% evaluated within 8 days after the date of hospitalization |
| 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 | Metropolitan 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) |
< 500 individuals |
| Details of the number of individuals | Registry: 700 Study: 364 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Paper observation notebook |
| Participant monitoring |
Yes |
| Details on monitoring of participants | M0 and M6 |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publication |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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