Thrombophilia Clinical Trial
Official title:
Arterial Microcirculation, Macrocirculation and Thrombophilias
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.
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.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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