CALIPSO - Prognostic value of peripheral arterial disease on 1-year ischemic outcomes in oupatients with a recent history of ACS 
Head :
Herrmann Marie-Annick, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb
Last update : 01/01/2019 | Version : 1 | ID : 137
| General | |
| Identification | |
| Detailed name | Prognostic value of peripheral arterial disease on 1-year ischemic outcomes in oupatients with a recent history of ACS |
| Sign or acronym | CALIPSO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N° 08.098 |
| General Aspects | |
| Medical area |
Cardiology |
| Others (details) | Peripheral Arterial Obstructive Disease (PAOD) in patients who have had an Acute coronary syndrome |
| Keywords | PAD, ABI, prognostic value, ischemic events, Cardiology, ACS, secondary prevention |
| Scientific investigator(s) (Contact) | |
| Name of the director | Herrmann |
| Surname | Marie-Annick |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| marie-annick.herrmann@bms.com | |
| Unit | Bristol-Myers Squibb |
| Name of the director | Schmidely |
| Surname | Nathalie |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| nathalie.schmidely@bms.com | |
| Unit | Bristol-Myers Squibb |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Bristol-Myers Squibb France / Sanofi Aventis France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Bristol-Myers Squibb France (BMS) |
| Organisation status |
Private |
| 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. | Random sampling in clusters. |
| Database objective | |
| Main objective | Determine the prognostic value of PAD (symptomatic or asymptomatic) on 1-year ischemic outcomes (death, myocardial ischemic recurrence, stroke, revascularization, rehospitalization for ischemic events) in patients with a recent ACS. |
| Inclusion criteria |
Register part : M/F patient, >=18 years, outpatient seen by private cardiologists, with a recent history of ACS with or without ST-segment elevation in the last 12 months. Study Part : patients from the register (2 first consecutive pts in the register without PAD) + (2 first consecutive patients in the register with symptomatic PAD or asymptomatic PAD and ABI < 0.9) |
| 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 | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | Registre/register : 2883 Cohorte/cohort :1760 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Biological data (detail) | fasting glucose, creatinine, glycosylated hemoglobin, total cholesterol, HDL, LDL, triglycerides |
| 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 | Paper CRF |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Month 0 and month 9 |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| 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 |
