Arterial Microcirculation, Macrocirculation and Thrombophilias (MICMAC)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Thrombophilia

Treatments: Other: Healthy volunteers; Other: Tests

Study type: Observational

Funder types: Other

Identifiers

NCT01160159

IDRCB 2008-A01635-50 (Other Identifier)

P071012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

Thrombophilia

Treatment:

Other: Tests

Healthy volunteers

Treatment:

Other: Healthy volunteers