Status:
UNKNOWN
Arterial Microcirculation, Macrocirculation and Thrombophilias
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Thrombophilia
Eligibility:
FEMALE
18-45 years
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-vascul...
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 propo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01160159
Start Date
March 1 2010
End Date
March 1 2012
Last Update
July 12 2010
Active Locations (1)
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1
Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase
Paris, France, 75004