Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-03 @ 12:08 PM
Study NCT ID:
NCT01734356
Status:
TERMINATED
Last Update Posted:
2014-11-07
First Post:
2012-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-06', 'studyFirstSubmitDate': '2012-11-22', 'studyFirstSubmitQcDate': '2012-11-22', 'lastUpdatePostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient'}], 'secondaryOutcomes': [{'measure': 'Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy'}]}, 'conditionsModule': {'keywords': ['iPS', 'fibroblast', 'arrhythmias', 'valvulopathies', 'electrophysiology', 'genetics'], 'conditions': ['Inherited Arrhythmias and Valvulopathies']}, 'descriptionModule': {'briefSummary': 'The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient with a family history of inherited arrhythmia or valvulopathy\n* Age : 22-60 yo.\n* patient no confine to bed\n* Male or female\n* Written consent\n* Patient affiliated to the French social security\n\nExclusion criteria:\n\n* Pregnant woman\n* Patient under 22 yo or adults under guardianship\n* Indication against local anesthesia\n* Anticoagulant treatment\n* Absence or positivity of HIV, HBV, HCV serology'}, 'identificationModule': {'nctId': 'NCT01734356', 'acronym': 'Diag-iPS', 'briefTitle': 'Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells', 'orgStudyIdInfo': {'id': 'BRD/10/11-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'inherited arrhythmias', 'description': '6 patient with inherited arrhythmias', 'interventionNames': ['Other: Skin biopsies']}, {'type': 'OTHER', 'label': 'valvulopathies', 'description': '6 patient with valvulopathies', 'interventionNames': ['Other: Skin biopsies']}, {'type': 'OTHER', 'label': 'controle', 'description': '8 healthy people for these pathologies', 'interventionNames': ['Other: Skin biopsies']}], 'interventions': [{'name': 'Skin biopsies', 'type': 'OTHER', 'armGroupLabels': ['controle', 'inherited arrhythmias', 'valvulopathies']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Vincent PROBST', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes UH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}