Spinal Cord Infarction Clinical Trial
— EDMIASOfficial title:
Descriptive Study of Acute Spontaneous Spinal Cord Infarction : EDMIAS
| NCT number | NCT04372758 |
| Other study ID # | RECHMPL20_0245 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 30, 2020 |
| Est. completion date | January 1, 2021 |
| Verified date | May 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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. Due 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. While 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. In 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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | January 1, 2021 |
| Est. primary completion date | December 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion criteria: - Hospitalized patients in a medical ward in Montpellier and Nîmes University Hospitals with registered diagnosis of vascular myelopathy - And final diagnosis of spontaneous SCI after reviewing medical datas Exclusion criteria: - non ischemic myelopathies : compression, hematomyelia, spinal DAVF, intramedullary tumor, inflammatory, infectious or post-infectious myelitis, post-radiation myelopathy,…) - secondary SCI : SCI following an aortic, cardiac or rachidian surgery, extracorporeal circulation, post-hemodynamic shock - SCI without a cause |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | description of a recent spontaneous SCI cohort | Number of patients hospitalized for spontaneous SCI in the last 10 years in Montpellier and Nîmes University Hospital | 10 years | |
| Primary | description of a recent spontaneous SCI cohort | description of patients diagnosed with spontaneous SCI | 1 day | |
| Secondary | evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies | evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies | 1 day | |
| Secondary | analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis | analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis | 1 day | |
| Secondary | Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015 | Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015 | 1 day | |
| Secondary | Retrospective evaluation of the potential candidates for IV thrombolysis | Retrospective evaluation of the potential candidates for IV thrombolysis | 1 day | |
| Secondary | Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI. | Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI. | 1 day |