MICMAC: Arterial Microcirculation, Macrocirculation and Thrombophilias

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT01160159

Collaborator

(none)

240

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombophilia	Other: Tests Other: Healthy volunteers

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Arterial Microcirculation, Macrocirculation and Thrombophilias

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2012

Anticipated Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Thrombophilia	Other: Tests Arterial parameters
Healthy volunteers	Other: Healthy volunteers Arterial parameters and blood test

Arm

Intervention/Treatment

Thrombophilia

Other: Tests

Arterial parameters

Healthy volunteers

Other: Healthy volunteers

Arterial parameters and blood test

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Capillary density [at 2 months max after inclusion]
Stiffness and arterial compliance [at 2 months max after inclusion]
Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software [at 2 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase	Paris		France	75004

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Chair: Anne GOMPEL, MD-PhD, Assistance Publique - Hôpitaux de Paris
Principal Investigator: Geneviève PLU-BUREAU, MD, PhD, Assistance Publique - Hôpitaux de Paris