Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT01160159
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT01160159
Study Brief:
Protocol Section:
NCT01160159