Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-03-15 @ 8:14 PM
Study NCT ID:
NCT02859532
Status:
UNKNOWN
Last Update Posted:
2019-01-07
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-04', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography', 'timeFrame': 'Day 0, Day 7, Day 30'}], 'secondaryOutcomes': [{'measure': 'Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated', 'timeFrame': 'Day 0, Day 7, Day 30'}, {'measure': 'Thrombus properties if provoked versus unprovoked thrombosis', 'timeFrame': 'Day 0, Day 7, Day 30'}, {'measure': 'Correlation of the thrombus in vivo properties to the thrombin generation capacity and viscoelastic properties tested ex vivo by rotational thromboelastometry', 'timeFrame': 'Day 0, Day 7, Day 30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['blood coagulation', 'Endogenous Thrombin Potential', 'rotational thromboelastometry'], 'conditions': ['Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus within the venous system, mainly the lower limbs. The clot structure directly influences both its location, but also its progressive profile expansion material or regression and embolic migration.\n\nFew data are available regarding the evolution of structural properties of thrombus after an acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how the thrombus responds to forces which it is subjected.\n\nDetermining the mechanical properties of the thrombus in vivo and ex vivo is expected to study its evolutionary properties.', 'detailedDescription': 'The main objective of the study is to characterize the in vivo properties of elastographic thrombus in patients with proximal deep vein thrombosis (DVT), for quantitative elastography performed at D0, D7, D30.\n\nThe ability to analyze the structural properties of the thrombus should allow us to then correlate these properties to the evolving nature of the thrombus (embolic migration or not, recanalization or not), and the effect of different treatment on the evolution of the thrombus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with proximal DVT, provoked or not, the symptomatology is less than 3d, with or without pulmonary embolism treated with heparin or oral anticoagulant\n* Signed informed consent\n* Patient affiliated to a social security scheme,\n\nExclusion Criteria:\n\n* pregnant or lactating\n* Life expectancy \\<1 month\n* Patient with distal DVT or asymptomatic DVT accidental discovery\n* Patient who underwent venous unclogging in acute phase\n* exclusion period in another study,\n* under administrative or judicial oversight, under guardianship'}, 'identificationModule': {'nctId': 'NCT02859532', 'acronym': 'ClotStruct', 'briefTitle': 'Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)', 'orgStudyIdInfo': {'id': '38RC15.355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnosis of deep vein thrombosis', 'description': 'All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test.', 'interventionNames': ['Radiation: elastography SWIRE']}], 'interventions': [{'name': 'elastography SWIRE', 'type': 'RADIATION', 'otherNames': ['Supersonic Imagine'], 'armGroupLabels': ['Diagnosis of deep vein thrombosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles Pernod', 'role': 'CONTACT'}], 'facility': 'University Hospital Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Gilles PERNOD', 'role': 'CONTACT', 'email': 'GPernod@chu-grenoble.fr', 'phone': '00 334 767 657 17'}], 'overallOfficials': [{'name': 'Gilles PERNOD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}