Arterial Microcirculation, Macrocirculation and Thrombophilias (MICMAC)

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.

Study Overview

• Status: Unknown
• Conditions: Thrombophilia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Anne GOMPEL, MD-PhD; Phone Number: 33(1)42-34-80-99; Email: anne.gompel@htd.aphp.fr

Study Locations

• France
  • Paris, France, 75004
    • Recruiting
    • Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase
    • Contact: Anne GOMPEL, MD,PhD; Phone Number: 33(1) 42-34-80-99; Email: anne.gompel@htd.aphp.fr
    • Principal Investigator: Geneviève PLU-BUREAU, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Other: Healthy volunteers; Arterial parameters and blood test
Thrombophilia	Other: Tests; Arterial parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vasodilatation endothelium-dependent (VDE)	at 2 months max after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ANTICIPATED): March 1, 2012
• Study Completion (ANTICIPATED): March 1, 2012

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (ESTIMATE): July 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2010
• Last Update Submitted That Met QC Criteria: July 9, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Women; Venous thrombosis; Arterial stiffness; IMT; Arterial compliance; Vasodilatation endothelium-dependent; Capillary density
• Additional Relevant MeSH Terms: Hematologic Diseases; Thrombophilia
• Other Study ID Numbers: P071012; IDRCB 2008-A01635-50 (OTHER: AFSSAPS)