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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