Arterial Microcirculation, Macrocirculation and Thrombophilias

Thrombophilia Clinical Trial

— MICMAC  

Official title:

Arterial Microcirculation, Macrocirculation and Thrombophilias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01160159
• Other study ID #: P071012
• Secondary ID: IDRCB 2008-A0163
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2010
• Last updated: July 9, 2010
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: February 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Anne GOMPEL, MD-PhD
• Phone: 33(1)42-34-80-99
• Email: anne.gompel[@]htd.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Thrombophilia

Intervention

Other:
• Tests
Arterial parameters
• Healthy volunteers
Arterial parameters and blood test

Locations

Country	Name	City	State
France	Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasodilatation endothelium-dependent (VDE)		at 2 months max after inclusion	No
Secondary	Capillary density		at 2 months max after inclusion	No
Secondary	Stiffness and arterial compliance		at 2 months max after inclusion	No
Secondary	Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software		at 2 month	No