ENDOCARDITIS - Repeated cross-sectional study for patients with infective endocarditis: surgical impact 
Head :
Alla Francois, CIC-EC INSERM CHU
Hoen Bruno, INFECTIOLOGIE CHU
Duval Xavier, CIC
Hoen Bruno, INFECTIOLOGIE CHU
Duval Xavier, CIC
Last update : 01/01/2018 | Version : 1 | ID : 60162
| General | |
| Identification | |
| Detailed name | Repeated cross-sectional study for patients with infective endocarditis: surgical impact |
| Sign or acronym | ENDOCARDITIS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 01/01/2009 |
| General Aspects | |
| Medical area |
Cardiology Infectious diseases |
| Keywords | Recurrence, valve surgery, hospitalisation, death |
| Scientific investigator(s) (Contact) | |
| Name of the director | Alla |
| Surname | Francois |
| Address | 54000 NANCY |
| f.alla@chu-nancy.fr | |
| Unit | CIC-EC INSERM CHU |
| Name of the director | Hoen |
| Surname | Bruno |
| Address | 25000 BESANCON |
| bruno.hoen@univ-fcomte.fr | |
| Unit | INFECTIOLOGIE CHU |
| Name of the director | Duval |
| Surname | Xavier |
| Address | 75018 PARIS |
| Phone | +33 (0)1 40 25 71 48 |
| xavier.duval@bch.aphp.fr | |
| Unit | CIC |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Involvement in a cohort: ICE |
| Funding | |
| Funding status |
Public |
| Details | PHRC |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Nancy |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Repeated cross-sectional studies (except case control studies) |
| 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. | Prospective |
| Database objective | |
| Main objective |
To assess the impact of surgical strategy on medium to long-term morbidity and mortality.
Secondary objective: descriptive and analytic. |
| Inclusion criteria | Patients over 18 years of age treated in hospital for definite (Duke) infective endocarditis (IE) in 2008. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 100 centres: Rhône-Alpes, Paris and immediate suburbs, Lorraine, Franche-Comté, Marne, Languedoc-Roussillon, Ille-et-Vilaine. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1991 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2008: 497 patients |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data Paraclinical data Biological data |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Information sheet at baseline and during follow-up supplied by the physicians. |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | Micro-organisms |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Clinical exams: manual input. Biological analysis: manual input. |
| Quality procedure(s) used | Request for consistency when data is processed electronically and after data is processed electronically. Missing data is managed by returning to source file or third party. Physicians contacted again for follow-up visits. Internal quality audit performed annually. SOP (Standard Operating Procedure) quality procedure. Patients are informed of the use of their data in writing. |
| Participant monitoring |
No |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDc |
| 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.
To be decided if 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 |
