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