Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-30 @ 2:18 AM
Study NCT ID:
NCT04372758
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2020-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptive Study of Acute Spontaneous Spinal Cord Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010264', 'term': 'Paraplegia'}, {'id': 'D011782', 'term': 'Quadriplegia'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'description of a recent spontaneous SCI cohort', 'timeFrame': '10 years', 'description': 'Number of patients hospitalized for spontaneous SCI in the last 10 years in Montpellier and Nîmes University Hospital'}, {'measure': 'description of a recent spontaneous SCI cohort', 'timeFrame': '1 day', 'description': 'description of patients diagnosed with spontaneous SCI'}], 'secondaryOutcomes': [{'measure': 'evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies', 'timeFrame': '1 day', 'description': 'evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies'}, {'measure': 'analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis', 'timeFrame': '1 day', 'description': 'analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis'}, {'measure': 'Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015', 'timeFrame': '1 day', 'description': 'Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015'}, {'measure': 'Retrospective evaluation of the potential candidates for IV thrombolysis', 'timeFrame': '1 day', 'description': 'Retrospective evaluation of the potential candidates for IV thrombolysis'}, {'measure': 'Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI.', 'timeFrame': '1 day', 'description': 'Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurology', 'Vascular disease', 'Paraplegia', 'Quadriplegia'], 'conditions': ['Spinal Cord Infarction', 'Spinal Cord Stroke', 'Vascular Myelopathy']}, 'descriptionModule': {'briefSummary': 'Acute spontaneous Spinal Cord Infarctions (SCI) are an uncommon cause of myelopathy (5%), but their prognostic is heterogeneous and frequently severe. Positive diagnosis is difficult, one quarter of initial MRIs are normal. Differential diagnosis with other transverse myelopathy causes is a common issue. As in cerebral stroke, there are multiple causes and mechanisms in spontaneous SCI, often difficult to clearly establish. There are also clinical and radiological patterns, sometimes misleading, according to vascular territory and its expanse.\n\nDue to its scarcity and heterogeneity, improving knowledge and medical care remains difficult. Medical care is still badly codified in medical literature. Recently, diagnostic criteria have been proposed to better identify SCI, provide earlier care and homogenize future research. External validity and reproduction of these new criteria among acute myelopathies are still to be validated.\n\nWhile there is no established medical treatment in the initial care of spontaneous SCI, some case reports show successful treatment with IV thrombolysis. Given the severe prognosis, conventional treatment of strokes (thrombolysis, anticoagulant and antiplatelet), could be considered on an individual scale, in a specific protocol. A better knowledge of radio-clinical and security factors are necessary to support this approach.\n\nIn order to respond to these difficulties, a retrospective cohort will allow us to better define epidemiological, clinico-radiological and prognostic features of spontaneous SCI. It lays the foundation of a possible prospective multicentric cohort, necessary for specific therapeutic studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All spontaneous SCI registered in medicine services from june 2010 to june 2020 in Montpellier University Hospital and Nîmes University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Hospitalized patients in a medical ward in Montpellier and Nîmes University Hospitals with registered diagnosis of vascular myelopathy\n* And final diagnosis of spontaneous SCI after reviewing medical datas\n\nExclusion criteria:\n\n* non ischemic myelopathies : compression, hematomyelia, spinal DAVF, intramedullary tumor, inflammatory, infectious or post-infectious myelitis, post-radiation myelopathy,…)\n* secondary SCI : SCI following an aortic, cardiac or rachidian surgery, extracorporeal circulation, post-hemodynamic shock\n* SCI without a cause'}, 'identificationModule': {'nctId': 'NCT04372758', 'acronym': 'EDMIAS', 'briefTitle': 'Descriptive Study of Acute Spontaneous Spinal Cord Infarction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Descriptive Study of Acute Spontaneous Spinal Cord Infarction : EDMIAS', 'orgStudyIdInfo': {'id': 'RECHMPL20_0245'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Nicolas Gaillard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}