Arterial Microcirculation, Macrocirculation and Thrombophilias

• Conditions: Thrombophilia
• Interventions: Other: Tests; Other: Healthy volunteers

• Registration Number: NCT01160159
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-19
• Study Start: 2010-03
• Study First Submitted QC: 2010-07-09
• Last Update Submitted: 2010-07-09
• Study First Posted: 2010-07-12
• Last Update Posted: 2010-07-12
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• healthy volunteers

  • 18-45 years old women of child bearing age
  • Without any hormonal contraception nor any hormone treatment since at least 3 months
  • Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking> 5 cigaret )
  • Patient who have signed an inform consent
  • With no thrombophilia : normal sample for factor V and II mutations
  • Willing to participate to the study
  • Adherent to health insurance
  • Previous Clinical examination

• women with thrombophilia

  • 18-45 years old women of child bearing age
  • Without any hormonal contraception nor any hormone treatment since at least 3 months
  • Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking> 5 cigaret )
  • Patient who have signed an inform consent
  • With thrombophilia : normal sample for factor V and II mutations
  • Willing to participate to the study
  • Adherent to health insurance
  • Previous Clinical examination

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Exclusion Criteria

• Women under hormonal contraception or who have stopped it less than 3 months ago
• Women under anticoagulant
• Arterial risk factor : HTA, diabetes, dyslipemia, obesity(BMI>30), including smoking> 5 cigarets ), metabolic syndrome, antiphospholipids/anticoagulant antibody, SLE
• History of coronaropathy or of stroke
• Pregnant women or willing to conceive
• Severe liver disease
• Women of less than 18y or older than 45y
• Severe liver diseases
• Patient not willing to sign up the inform consent
• Patient refusal to participate
• Endometrial cancer
• Unexplored bleeding
• Women not willing to participate or included in another trial
• Woman with another thrombophilic disorder (ATIII, protein C, S, history of VTE without any biological thrombophilic disorder.
• Women with at least one of the following treatment and who cannot stop it 48h before the arterial investigations.
• Gynergen caffeine
• NOCERTONE® oxetorone
• SIBÉLIUM®flunarizine
• VIDORA®indoramine
• SANMIGRAN® 0,50 mg pizotifen
• woman under propranolol AVLOCARDYL® 40 mg *AVLOCARDYL® LP 160 mg

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thrombophilia	Tests	-
Healthy volunteers	Healthy volunteers	-

Primary Outcome Measures

Name	Time	Method
Vasodilatation endothelium-dependent (VDE)	at 2 months max after inclusion

Secondary Outcome Measures

Name	Time	Method
Capillary density	at 2 months max after inclusion
Stiffness and arterial compliance	at 2 months max after inclusion
Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software	at 2 month

Trial Locations

Locations (1)

Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase; 🇫🇷 Paris, France