I-SYPRES - 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 ARCHIVE

Head :
Herrmann Marie-Annick, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb

Last update : 01/01/2019 | Version : 1 | ID : 134

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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 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
Email 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
Email 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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