Clinical trial NCT01160159: Arterial Microcirculation, Macrocirculation and Thrombophilias
Official title: Arterial Microcirculation, Macrocirculation and Thrombophilias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombophilia
Keywords: Venous thrombosis
Women
Vasodilatation endothelium-dependent
IMT
Arterial stiffness
Arterial compliance
Capillary density
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Vasodilatation endothelium-dependent (VDE)
timeFrame: at 2 months max after inclusion
Secondary outcomes:
measure: Capillary density
timeFrame: at 2 months max after inclusion
measure: Stiffness and arterial compliance
timeFrame: at 2 months max after inclusion
measure: Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software
timeFrame: at 2 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne GOMPEL, MD-PhD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Geneviève PLU-BUREAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: