Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT01160159
Status:
UNKNOWN
Last Update Posted:
2010-07-12
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Microcirculation, Macrocirculation and Thrombophilias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vasodilatation endothelium-dependent (VDE)', 'timeFrame': 'at 2 months max after inclusion'}], 'secondaryOutcomes': [{'measure': 'Capillary density', 'timeFrame': 'at 2 months max after inclusion'}, {'measure': 'Stiffness and arterial compliance', 'timeFrame': 'at 2 months max after inclusion'}, {'measure': 'Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software', 'timeFrame': 'at 2 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Venous thrombosis', 'Women', 'Vasodilatation endothelium-dependent', 'IMT', 'Arterial stiffness', 'Arterial compliance', 'Capillary density'], 'conditions': ['Thrombophilia']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary objective: To measure endothelium dependent vasodilatation (VDE) in controls and in women with thrombophilia.', 'detailedDescription': '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.\n\nDesign: It is a prospective open transversal trial.\n\nManagement 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.\n\nPrincipal criteria: measurement of EDV.\n\nSecondary criteria: capillar density, arterial compliance and stiffness and retinogram.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\n * 18-45 years old women of child bearing age\n * Without any hormonal contraception nor any hormone treatment since at least 3 months\n * Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking\\> 5 cigaret )\n * Patient who have signed an inform consent\n * With no thrombophilia : normal sample for factor V and II mutations\n * Willing to participate to the study\n * Adherent to health insurance\n * Previous Clinical examination\n* women with thrombophilia\n\n * 18-45 years old women of child bearing age\n * Without any hormonal contraception nor any hormone treatment since at least 3 months\n * Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking\\> 5 cigaret )\n * Patient who have signed an inform consent\n * With thrombophilia : normal sample for factor V and II mutations\n * Willing to participate to the study\n * Adherent to health insurance\n * Previous Clinical examination\n\nExclusion Criteria:\n\n* Women under hormonal contraception or who have stopped it less than 3 months ago\n* Women under anticoagulant\n* Arterial risk factor : HTA, diabetes, dyslipemia, obesity(BMI\\>30), including smoking\\> 5 cigarets ), metabolic syndrome, antiphospholipids/anticoagulant antibody, SLE\n* History of coronaropathy or of stroke\n* Pregnant women or willing to conceive\n* Severe liver disease\n* Women of less than 18y or older than 45y\n* Severe liver diseases\n* Patient not willing to sign up the inform consent\n* Patient refusal to participate\n* Endometrial cancer\n* Unexplored bleeding\n* Women not willing to participate or included in another trial\n* Woman with another thrombophilic disorder (ATIII, protein C, S, history of VTE without any biological thrombophilic disorder.\n* Women with at least one of the following treatment and who cannot stop it 48h before the arterial investigations.\n* Gynergen caffeine\n* NOCERTONE® oxetorone\n* SIBÉLIUM®flunarizine\n* VIDORA®indoramine\n* SANMIGRAN® 0,50 mg pizotifen\n* woman under propranolol AVLOCARDYL® 40 mg \\*AVLOCARDYL® LP 160 mg'}, 'identificationModule': {'nctId': 'NCT01160159', 'acronym': 'MICMAC', 'briefTitle': 'Arterial Microcirculation, Macrocirculation and Thrombophilias', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Arterial Microcirculation, Macrocirculation and Thrombophilias', 'orgStudyIdInfo': {'id': 'P071012'}, 'secondaryIdInfos': [{'id': 'IDRCB 2008-A01635-50', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thrombophilia', 'interventionNames': ['Other: Tests']}, {'label': 'Healthy volunteers', 'interventionNames': ['Other: Healthy volunteers']}], 'interventions': [{'name': 'Tests', 'type': 'OTHER', 'description': 'Arterial parameters', 'armGroupLabels': ['Thrombophilia']}, {'name': 'Healthy volunteers', 'type': 'OTHER', 'description': 'Arterial parameters and blood test', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne GOMPEL, MD,PhD', 'role': 'CONTACT', 'email': 'anne.gompel@htd.aphp.fr', 'phone': '33(1) 42-34-80-99'}, {'name': 'Geneviève PLU-BUREAU, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Anne GOMPEL, MD-PhD', 'role': 'CONTACT', 'email': 'anne.gompel@htd.aphp.fr', 'phone': '33(1)42-34-80-99'}], 'overallOfficials': [{'name': 'Anne GOMPEL, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Geneviève PLU-BUREAU, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Myriem CARRIER', 'oldOrganization': 'Department of clinical research and development'}}}}