ITMO public health
Last update : 07/07/2015 | Version : 1 | ID : 60075
| General | |
| Identification | |
| Detailed name | Cohort of Males Aged 50-59 Years Old: Prospective Myocardial Infarction Study |
| Sign or acronym | PRIME |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL approval |
| General Aspects | |
| Medical area |
Cardiology |
| Health determinants |
Genetic Lifestyle and behavior Nutrition Occupation |
| Keywords | ischaemic heart disease, cardiovascular events, health events, cancer |
| Scientific investigator(s) (Contact) | |
| Name of the director | Ducimetière |
| Surname | Pierre |
| pierre.ducimetiere@inserm.fr | |
| Unit | U780 |
| Organization | INSERM - Institut National de Santé et Recherche |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Cohort network involvement: MORGAN INTERNATIONAL CONSORTIUM: COHORT CONSORTIUM, COLLABORATION WITH THE CAMBRIDGE TEAM: CVA FIBRINOGEN STUDY COLLABORATION. |
| Funding | |
| Funding status |
Mixed |
| Details | Merck and public. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Inclusion method: prospective. |
| Database objective | |
| Main objective | General objective: prospective and epidemiological study on ischaemic cardiac events. |
| Inclusion criteria | Sample of 50-59-year old males. |
| Population type | |
| Age |
Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male |
| Geography area |
Local |
| French regions covered by the database |
Alsace Champagne-Ardenne Lorraine Languedoc-Roussillon Midi-Pyrénées Nord - Pas-de-Calais Picardie |
| Detail of the geography area | Multicentric cohort (4 centres): LILLE, TOULOUSE, BELFAST and STRASBOURG. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1991 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 10,592 |
| 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 |
| Details of collected clinical data | Clinical examination at baseline. Information collected during clinical examination: anthropometric measurements, blood pressure, heart rate, LSHTM chest pain questionnaire, ECG, treatment. |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Self-administered questionnaire at baseline and during follow-up every year. Information collected by self-administered questionnaire: at baseline: demographic, socioeconomic and dietetic data; follow-up: clinical events. Interview questionnaire at baseline. Information collected during interview: additional questions: social and education level, work and activities, personal history, family history, smoking, diet, alcohol consumption, drug use, physical activity, symptoms and psychosocial factors. |
| Paraclinical data (detail) | Waist-hip ratio. |
| Biological data (detail) | Type of samples taken: Blood. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA |
| Details of biobank content | Serum bank, plasma bank, DNA bank. |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Self-administered questionnaire: from a paper questionnaire. Interview: from a paper questionnaire. Clinical examination: handwritten. |
| Quality procedure(s) used | Consistency request after electronic data is recorded. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 10 years. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | PATIENT HOSPITAL RECORD OR TREATING PHYSICIAN'S RECORD FOR FOLLOW-UP AND NOT FOR ENROLMENT, MORTALITY REGISTRY. |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Data may be used by academic teams.
Data may be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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