NCT01160159

Arterial Microcirculation, Macrocirculation and Thrombophilias

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Thrombophilia

Interventions

Type	Name	Description
OTHER	Tests	Arterial parameters
OTHER	Healthy volunteers	Arterial parameters and blood test

Timeline

• Start date: 2010-03-16
• Primary completion: 2010-04-16
• Completion: 2010-04-16
• First posted: 2010-07-12
• Last updated: 2026-04-06

Locations

1 site across 1 country: France