OPTIMEV - Optimising History Taking for Evaluating The Risk of Venous Thromboembolism

Head :
Bosson Jean-Luc, CIC GrenobleEquipe Themas laboratoire TIMC Imag UMR CNRS 5525
Sevestre Marie Antoinette

Last update : 07/21/2015 | Version : 2 | ID : 5361

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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 Optimising History Taking for Evaluating The Risk of Venous Thromboembolism
Sign or acronym OPTIMEV
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation N° CCTIRS : 04-459 N° CNIL : 905040 –05-1118 N° CLINICALTRIALS : NCT00670540
General Aspects
Medical area Cardiology
Hematology
Pneumology
Keywords lower limb deep vein thrombosis, superficial venous thrombosis, post-thrombotic syndrome, pulmonary embolism, Venous thromboembolism, chronic disease, quality of life
Scientific investigator(s) (Contact)
Name of the director Bosson
Surname Jean-Luc
Address Pole Santé Publique pavillon taillefer Chu Grenoble 38700 La Tronche
Phone + 33 (0)4 76 76 50 47
Email jlbosson@imag.fr
Unit CIC GrenobleEquipe Themas laboratoire TIMC Imag UMR CNRS 5525
Organization INSERM - Institut National de la Santé et de la Recherche
Name of the director Sevestre
Surname Marie Antoinette
Address Service de Médecine Vasculaire CHU Amiens
Email sevestre.marie-antoinette@chu-amiens.fr
Organization CHU
Collaborations
Funding
Funding status Mixed
Details Le programme hospitalier de recherche clinique PHRCSanofi AventisCIC Grenoble et service de Médecine Vasculaire Grenoble
Governance of the database
Sponsor(s) or organisation(s) responsible INSERM - Institut National de la Santé et de la Recherche Médicale
Organisation status Public
Sponsor(s) or organisation(s) responsible Société Française de Médecine Vasculaire
Organisation status Public
Sponsor(s) or organisation(s) responsible CHU Grenoble
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health care professionals
A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Patients referred to a vascular medicine physician for clinically suspected thromboembolism. All patients are enrolled after been seen in one day over 4 recruitment periods (4 seasons)
Database objective
Main objective To evaluate current risk factors that fit today's practice and long-term prognosis for different anatomical and clinical forms of symptomatic thromboembolism (proximal and distal deep vein thrombosis, superficial venous thrombosis, pulmonary embolism) Follow-up covers recurrent VTE, arterial thrombotic events (coronary, CVA, PAD), onset of cancer, haemorrhagic stroke, post-thrombotic syndrome and death.
Inclusion criteria Adult patients with clinical signs of symptomatic thromboembolism classified after inclusion for VTE+ patients (thromboembolism confirmed through further objective examination) or VTE- patients (thromboembolism ruled out by further examination)
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, 350 investigating vascular medicine physicians from CHU, CHG, clinics and private practices
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2006
Date of last collection (YYYY or MM/YYYY) 2014
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 8256
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Paraclinical data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Phone interview
Paraclinical data (detail) Doppler ultrasonography and Pulmonary CT examination report, hospital report
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Quality of life/health perception
Procedures
Data collection method Patient characteristics entered at baseline on an e-CRF where quality is monitored electronically Follow-up entered after all target events were validated by a critical events committee (2 physicians evaluating examination and hospital reports) by CRA on an e-CRF
Participant monitoring Yes
Details on monitoring of participants Clinical research associates specialising in vascular disease conducted follow-up telephone interviews with PTS evaluation (Villalta score), quality of life evaluation as well as events involving venous and arterial thrombosis, cancer, haemorrhagic stroke and death.
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://recherche-clinique.ujf-grenoble.fr/OPTIMEV/
Link to the document http://tinyurl.com/OPTIMEV
Description List of publications in HAL
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=optimev+AND+%28Bosson+JL[Author]+OR+Sevestre+MA[Author]%29+OR+22429908[uid]
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) Publications
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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