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Arterial Microcirculation, Macrocirculation and Thrombophilias (MICMAC)

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ClinicalTrials.gov Identifier: NCT01160159
Recruitment Status : Unknown
Verified February 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : July 12, 2010
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:

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
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
Estimated Enrollment : 240 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Arterial Microcirculation, Macrocirculation and Thrombophilias
Study Start Date : March 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Vasodilatation endothelium-dependent (VDE) [ Time Frame: at 2 months max after inclusion ]

Secondary Outcome Measures :
  1. Capillary density [ Time Frame: at 2 months max after inclusion ]
  2. Stiffness and arterial compliance [ Time Frame: at 2 months max after inclusion ]
  3. Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software [ Time Frame: at 2 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160159


Contacts
Contact: Anne GOMPEL, MD-PhD 33(1)42-34-80-99 anne.gompel@htd.aphp.fr

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

Responsible Party: Myriem CARRIER, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT01160159     History of Changes
Other Study ID Numbers: P071012
IDRCB 2008-A01635-50 ( Other Identifier: AFSSAPS )
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: February 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Venous thrombosis
Women
Vasodilatation endothelium-dependent
IMT
Arterial stiffness
Arterial compliance
Capillary density

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases