Arterial Microcirculation, Macrocirculation and Thrombophilias

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01160159
• Date of registration: 19/02/2010
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Arterial Microcirculation, Macrocirculation and Thrombophilias MICMAC
• Scientific title: Arterial Microcirculation, Macrocirculation and Thrombophilias
• Date of first enrolment: March 2010
• Target sample size: 240
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01160159
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Anne GOMPEL, MD,PhD

• Name: Anne GOMPEL, MD-PhD

• Name: Anne GOMPEL, MD-PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

• Name: Geneviève PLU-BUREAU, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Thrombophilia

Intervention(s)

Other: Healthy volunteers

Other: Tests

Primary Outcome(s)

Vasodilatation endothelium-dependent (VDE) [Time Frame: at 2 months max after inclusion]

Secondary Outcome(s)

Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software [Time Frame: at 2 month]

Stiffness and arterial compliance [Time Frame: at 2 months max after inclusion]

Capillary density [Time Frame: at 2 months max after inclusion]

Secondary ID(s)

IDRCB 2008-A01635-50

P071012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors