ITMO public health
Last update : 10/26/2017 | Version : 1 | ID : 2787
| General | |
| Identification | |
| Detailed name | French Cost Of Acute STroke |
| Sign or acronym | French COAST |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 10.295, CNIL 910284 |
| General Aspects | |
| Medical area |
Neurology |
| Health determinants |
Medicine |
| Keywords | Stroke, functional disability, fatigue, depression, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | BLIN |
| Surname | Patrick |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | 05 57 57 46 75 |
| patrick.blin@u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux |
| Organization | Université Bordeaux |
| Name of the director | MOORE |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | 05 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Laboratoire Lundbeck (soutien inconditionnel) - Lundbeck (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Créativ-Ceutical |
| Organisation status |
Private |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | All patients admitted for a CI confirmed by imaging at the University Hospital of Bordeaux, Pellegrin hospital, are included in the study over a period of two months. Written consent of the patient or person of trust marks inclusion of the patient in the study |
| Database objective | |
| Main objective | The main objective is to determine the impact of the organization of acute care (medical, paramedical and therapeutic care) for patients with cerebral infarction on short and long term vital and functional prognosis. |
| Inclusion criteria | Patient with a cerebral infarction confirmed by imaging (scan or MRI); not hospitalized for complications or side effects or for further assessment of a recent cerebral infarctionI; agreeing to participate and not affected by a language barrier. |
| 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 |
| Pathology | I63 - Cerebral infarction |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Bordeaux University Hospital – Pellegrin hospital |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 129 patients included |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Face to face interview Phone interview |
| Details of collected declarative data | HADS, FSS, EQ-5D, MRS scales, and questionnaire on resources use |
| Administrative data (detail) | Patient name, first name, date and place of birth, phone number and address, contact details of the general practitioner. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception Others |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Quality of life/perceived health (detail) | HADS, FSS, EQ-5D scales |
| Other (detail) | Modified Rankin Scale |
| Procedures | |
| Data collection method | Data collection is performed through an eCRF by a Clinical Research Assistant at the Pellegrin hospital during the inclusion phase and by telephone during the follow-up phase. |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Details on monitoring of participants | The follow-up is 12 months. Patients are contacted every 3 months to answer a telephone questionnaire (healthcare consumption since the last contact, scales on fatigue, depression, quality of life and functional disability). Vital status at one year included will be determined by the INSEE / INSERM procedure. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | RNIPP (vital status) |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | The statistical analyses and study report were performed by Creativ-Ceutical. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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