Clinical trial NCT04372758: Descriptive Study of Acute Spontaneous Spinal Cord Infarction
Official title: Descriptive Study of Acute Spontaneous Spinal Cord Infarction : EDMIAS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Infarction
Spinal Cord Stroke
Vascular Myelopathy
Keywords: Neurology
Vascular disease
Paraplegia
Quadriplegia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
First posted: 2020-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All spontaneous SCI registered in medicine services from june 2010 to june 2020 in Montpellier University Hospital and Nîmes University Hospital

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: description of a recent spontaneous SCI cohort
timeFrame: 10 years
measure: description of a recent spontaneous SCI cohort
timeFrame: 1 day
Secondary outcomes:
measure: evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies
timeFrame: 1 day
measure: analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis
timeFrame: 1 day
measure: Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015
timeFrame: 1 day
measure: Retrospective evaluation of the potential candidates for IV thrombolysis
timeFrame: 1 day
measure: Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas Gaillard, MD
role: PRINCIPAL_INVESTIGATOR
References: