Arterial Microcirculation, Macrocirculation and Thrombophilias (MICMAC)
Recruitment status was: Recruiting
Rationale: To analyse the arterial state of women with thrombophilia by techniques studying micro and arterial macrocirculation because of a reported and still discussed increase risk in cardio-vascular events in these women.
Primary objective: To measure endothelium dependent vasodilatation (VDE) in controls and in women with thrombophilia.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Arterial Microcirculation, Macrocirculation and Thrombophilias|
- Vasodilatation endothelium-dependent (VDE) [ Time Frame: at 2 months max after inclusion ] [ Designated as safety issue: No ]
- Capillary density [ Time Frame: at 2 months max after inclusion ] [ Designated as safety issue: No ]
- Stiffness and arterial compliance [ Time Frame: at 2 months max after inclusion ] [ Designated as safety issue: No ]
- Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software [ Time Frame: at 2 month ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Other: Healthy volunteers
Arterial parameters and blood test
There are several papers reporting an increase in the risk of arterial diseases in women with thrombophilia. However these reports remain controversial. In order to gain insight on that issue we propose to study the micro and macrocirculation in women with an history of venous thrombosis or thrombophilia and in controls matched by age.
Design: It is a prospective open transversal trial.
Management of the study: Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia. Following an inclusion consultation where the informed consent will be obtained and inclusion criteria checked, an appointment for the arterial explorations will be given. These explorations will be measurement of endothelium dependent vasodilatation (EDV), capillar density, arterial fitness and compliance and retinogram. There is no follow-up visit.Benefits and risks: the measurement will characterize the arterial state of patients with thrombophilia included in the study.There is no risk in performing these techniques.
Principal criteria: measurement of EDV.
Secondary criteria: capillar density, arterial compliance and stiffness and retinogram.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160159
|Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase|
|Paris, France, 75004|
|Study Chair:||Anne GOMPEL, MD-PhD||Assistance Publique - Hôpitaux de Paris|
|Principal Investigator:||Geneviève PLU-BUREAU, MD, PhD||Assistance Publique - Hôpitaux de Paris|