ITMO public health
Last update : 09/19/2016 | Version : 2 | ID : 5047
| General | |
| Identification | |
| Detailed name | Prediction of Damage to Organs: Prospective Cohort Study in The General Population on Brain and Cardiovascular Ageing |
| Sign or acronym | Mona Lisa - PREDOR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Cardiology Geriatrics Neurology |
| Keywords | Prediction, alteration, response to cognitive and psychometric tests, seven years, predictive factors, cardiovascular risk |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bongard |
| Surname | Vanina |
| Address | CHU de Toulouse – Université Toulouse III Paul Sabatier UMR 1027, INSERM – Université Toulouse III Faculté de Médecine, 37 allées Jules Guesde, 31062 Toulouse Cedex 9 |
| Phone | + 33 (0)5 61 14 59 49 |
| Vanina.bongard@univ-tlse3.fr | |
| Unit | UMR 1027 (Epidémiologie et analyses en Santé Publique) Equipe 3 (Epidémiologie de l’athérosclérose et des maladies cardiovasculaires) |
| Organization | CHU |
| Name of the director | Ferrières |
| Surname | Jean |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Crédits de revitalisation, Appel d’Offres Local Délégation à la Recherche Clinique et l’Innovation, CHU de Toulouse, Industrie |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Toulouse |
| 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 population file |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | 1,200 subjects (men and women) between 42 and 79 years of age, living in Haute-Garonne, randomly selected from 1,600 subjects who participated in the MONA LISA survey in 2005. 300 subjects (men and women) between 80 and 89 years of age, living in Haute-Garonne, recruited de novo by random selection from electoral registers. |
| Database objective | |
| Main objective | Main objectives: - To identify predictors of impaired response to psychometric and cognitive tests and an altered level of cardiovascular risk over a period of seven years. - To develop corresponding risk prediction formulas. Secondary objectives: - To compare responses to psychometric and cognitive tests according to age. - To assess the prevalence of fragility syndrome according to age. - To assess the prevalence of dependency in subjects over 60 years old. - To identify predictive factors of the onset of fragility syndrome or dependency from a follow-up initiated in 2012. - On a sub-sample of 500 subjects that have undergone cerebral imaging (PET scan + MRI): - To assess the prevalence of the presence of cerebral amyloid deposits in the general population according to age. - To quantify the significance of cerebral amyloid deposits in terms of age. - To describe the relationship between cerebral amyloid deposits and response to psychometric and cognitive tests. - To identify factors associated with the presence of cerebral amyloid deposits. |
| Inclusion criteria | Subjects between 42 and 89 years old, from both genders, living in Haute-Garonne, randomly selected from electoral registers and covered by a social security scheme of equivalent. |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Departmental |
| French regions covered by the database |
Languedoc-Roussillon Midi-Pyrénées |
| Detail of the geography area | Haute-Garonne |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1500 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Medical registration |
| Paraclinical data (detail) | Psychometric and cognitive tests (storage and retrieval of words, Wechsler Adult Intelligence Survey - Digit Symbol Substitution Subtest (WAISS-DSST), Stroop test, verbal fluency test) (Mini Mental State Examination (MMSE)), and for cognitive impairment cases: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-COG) and Clinical Dementia Rating (CDR)), as well as an assessment of frailty syndrome (Fried criteria) and dependence (basic Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL)) |
| Biological data (detail) | Glucose, haemoglobin A1c, lipid profile, creatinine, transaminases, insulin level, ECG, measurement of body fat |
| Administrative data (detail) | Socio-economic and demographic characteristics, education level, personal and family medical history |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA |
| Details of biobank content | Serum, plasma, DNA |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | During clinical examination: weight, height, waist and hip measurement, heart rate, arterial blood pressure, systolic blood pressure index |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Annual follow-up from 2012 and re-evaluation in 5 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=MONA+LISA+AND+Bongard+V+%5BAuthor%5D |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23275371 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24083967 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23527913 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23275371 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24083967 |
| 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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