COFRASA / GENERAC - Factors Favouring Aortic Stenosis
Head :
Messika-Zeitoun David, SERVICE DE CARDIOLOGIE DU PROFESSEUR VAHANIAN
Last update : 07/03/2014 | Version : 1 | ID : 60116
| General | |
| Identification | |
| Detailed name | Factors Favouring Aortic Stenosis |
| Sign or acronym | COFRASA / GENERAC |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL : 31/07/2006 |
| General Aspects | |
| Medical area |
Cardiology |
| Others (details) | Aortic stenosis |
| Keywords | heart failure, aortic valve replacement, aortic valve, vascular atherosclerotic disease, Death, myocardial infarction, stroke, intima-media. |
| Scientific investigator(s) (Contact) | |
| Name of the director | Messika-Zeitoun |
| Surname | David |
| Address | 75018 PARIS |
| david.messika-zeitoun@bch.aphp.fr | |
| Unit | SERVICE DE CARDIOLOGIE DU PROFESSEUR VAHANIAN |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | AP-HP, DRC |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | AP-HP |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Other bodies active in creating this cohort: CHU, CHG, independent physicians, multiple recruitment sources but centralised evaluation at Bichat Inclusion cut-off date: 01/01/2011 |
| Database objective | |
| Main objective | To determine factors favouring aortic stenosis progression and more specifically the effect of biological markers for inflammation, coagulation, platelet aggregation and matrix metalloproteinases. Secondary objectives: - To assess the relationship between the increase in AS and progression of vascular atherosclerosis; - To research genetic susceptibility factors associated with AS with candidate genes (fetuin-A, matrix-GLA protein, vitamin D receptor) and genomewide association studies; - To identify the relationships between genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor with 1) plasma levels for fetuin-A, MGP, vitamin D and parathyroid hormone, 2) haemodynamic severity stenosis and 3) the progression of AS. |
| Inclusion criteria | Patient group (aortic sentosis) - age >=18 years - pure (no or minimal aortic valve stenosis), isolated (no valve disease >= grade 2/4), "degenerative" aortic valve stenosis; - no known severe renal insufficiency (creatinine clearance < 30 ml/min); - Patients affiliated with a social security scheme. Control group: age >=18 years, no known first degree relative with aortic valve stenosis: no valve disease >= grade 2/4; - no known severe renal insufficiency (creatinine clearance < 30 ml/min); - - Patients affiliated with a social security scheme. |
| 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 |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Île-de-France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 11/2006 |
| Date of last collection (YYYY or MM/YYYY) | 01/2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | - 1000 patients présentant un rétrécissement aortique / cases - 1500 contrôles / controls |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview |
| Paraclinical data (detail) | Imaging: echocardiography, carotid ultrasound, ECG. |
| Biological data (detail) | Blood (+ aortic valve specimen for operated patients) |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma DNA |
| Details of biobank content | Serum bank, plasma bank, DNA bank, tissue bank (aortic valve specimen for operated patients) |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Interview: from a paper questionnaire with double data entry. Clinical examinations: handwritten with double data entry. Clinical examinations: handwritten with double data entry. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 2 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23768690 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23349346 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23329150 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams: open to ancillary projects and replication of genetic studies. Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
