ITMO public health
Last update : 10/26/2017 | Version : 2 | ID : 2818
| General | |
| Identification | |
| Detailed name | Observational study of Long-term follow-up of post-myocardial infarction |
| Sign or acronym | EOLE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTIRS 05.484, CNIL 906042 |
| General Aspects | |
| Medical area |
Cardiology |
| Health determinants |
Lifestyle and behavior Medicine Nutrition Occupation |
| Keywords | Acute Myocardial Infarction (AMI), lifestyle and dietary recommendations, cardiovascular treatments, secondary prevention, mortality, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41- 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | Blin |
| Surname | Patrick |
| Address | Bât du Tondu - Case 41- 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| patrick.blin@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Details | Pierre Fabre Médicament (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| 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 care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Patients are included by cardiologists who are themselves selected from a random sample of hospital and non-hospital cardiologists in metropolitan France. |
| Database objective | |
| Main objective | The main objective is to assess in real situations of use the impact of cardiovascular medications and recommended lifestyle and dietary recommendations on all-cause mortality in secondary prevention of myocardial infarction. |
| Inclusion criteria | Patient with recent (≤3 months) acute myocardial infarction (first or recurrent heart attack); Patient seen during the first or second consultation after acute myocardial infarction; Infarct defined by the presence at least of two among the following criteria: symptomatic (characteristic pain), electric (Q wave and / or ST elevation in at least two adjacent leads), enzymatic (elevated CPKMB and / or troponin greater than 2 twice the normal value); Patient who may be followed for 6 years; Patient without a non-cardiovascular disease that is life-threatening in the short term (≤3 months); Patient not included in a clinical trial of an non marketed drug; Patient not affected by a language barrier (unable to read the information sheet or complete the self-administered questionnaires); Patient agreeing to participate. |
| 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 |
National |
| Detail of the geography area | Hospital and non-hospital cardiologists in metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2015 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 5538 |
| 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) |
Paper self-questionnaire Internet self-questionnaire Phone interview |
| Details of collected declarative data | Questionnaire diet, physical activity before and after myocardial infarction, tobacco use, drugs taken, and hospitalisations after myocardial infarction of inclusion |
| 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 |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | Inclusion data are collected by cardiologists and patients via a paper questionnaire. Follo-up data are collected by cardiologists (only at 6 and 24 months of follow up in the first includion period ) and by patients via an eCRF or a paper questionnaire. |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Details on monitoring of participants | The total follow-up is 6 years with an evaluation at 6 months, 24 months, 3 years 4 years 5 years 6 years via a self-administered questionnaire. Patients may fill-out these questionnaires via the internet (eCRF) or by postal mail using a paper questionnaire. The data collected in this questionnaire concern dietary habits since the AMI (only at 6 and 24 months of follow-up for patients included during the first inclusion period), treatments taken, physical activity, smoking, current health status, and hospitalizations. Follow-up by cardiologists concerns only patients included in the first inclusion period with an evaluation at 6 and 24 months (vital status, cardiovascular events, clinical and laboratory data, prescribed cardiovascular treatments). Vital status determination of included patients at 3.5 years and 6 years will be performed using the INSERM / INSEE procedure. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | RNIPP, CéPIDC |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/EOLE/ |
| Description | List of publications in HAL |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Confidential study reports are submitted to the Pharmaceutical company and health authorities. The study reports and scientific communications (posters, articles, ...) are validated by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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