Arterial Microcirculation, Macrocirculation and Thrombophilias

NCT ID: NCT01160159

Last Updated: 2010-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-03-31

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.

Conditions

Thrombophilia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Thrombophilia

Tests

Intervention Type: OTHER

Arterial parameters

Healthy volunteers

Healthy volunteers

Intervention Type: OTHER

Arterial parameters and blood test

Interventions

Tests

Arterial parameters

Intervention Type: OTHER

Healthy volunteers

Arterial parameters and blood test

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department of clinical research and development

Principal Investigators

Anne GOMPEL, MD-PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Geneviève PLU-BUREAU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Anne GOMPEL, MD-PhD

Role: CONTACT

anne.gompel@htd.aphp.fr

33(1)42-34-80-99

Facility Contacts

Anne GOMPEL, MD,PhD

Role: primary

anne.gompel@htd.aphp.fr

33(1) 42-34-80-99

Other Identifiers

IDRCB 2008-A01635-50

Identifier Type: OTHER

Identifier Source: secondary_id

P071012

Identifier Type: -

Identifier Source: org_study_id