NCT01160159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 12, 2010

Status Verified

February 1, 2010

Enrollment Period

2 years

First QC Date

February 19, 2010

Last Update Submit

July 9, 2010

Conditions

Thrombophilia

Keywords

Venous thrombosisWomenVasodilatation endothelium-dependentIMTArterial stiffnessArterial complianceCapillary density

Outcome Measures

Primary Outcomes (1)

  • Vasodilatation endothelium-dependent (VDE)

    at 2 months max after inclusion

Secondary Outcomes (3)

  • 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

Study Arms (2)

Thrombophilia

Other: Tests

Healthy volunteers

Other: Healthy volunteers

Interventions

TestsOTHER

Arterial parameters

Thrombophilia
Healthy volunteersOTHER

Arterial parameters and blood test

Healthy volunteers

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • healthy volunteers
  • 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
  • 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
  • +3 more criteria

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase

Paris, 75004, France

RECRUITING

MeSH Terms

Conditions

ThrombophiliaVenous Thrombosis

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne GOMPEL, MD-PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Geneviève PLU-BUREAU, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne GOMPEL, MD-PhD

CONTACT

33(1)42-34-80-99anne.gompel@htd.aphp.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2010

First Posted

July 12, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 12, 2010

Record last verified: 2010-02

Locations

FR(1)