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Completed

NCT Number: NCT04372758

Descriptive Study of Acute Spontaneous Spinal Cord Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. description of a recent spontaneous SCI cohort

    Time frame: 10 years

    Number of patients hospitalized for spontaneous SCI in the last 10 years in Montpellier and Nîmes University Hospital

  2. description of a recent spontaneous SCI cohort

    Time frame: 1 day

    description of patients diagnosed with spontaneous SCI

Secondary outcomes

  1. evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies

    Time frame: 1 day

    evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies

  2. analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis

    Time frame: 1 day

    analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis

  3. Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015

    Time frame: 1 day

    Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015

  4. Retrospective evaluation of the potential candidates for IV thrombolysis

    Time frame: 1 day

    Retrospective evaluation of the potential candidates for IV thrombolysis

  5. Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI.

    Time frame: 1 day

    Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Registry information

Official study title

Descriptive Study of Acute Spontaneous Spinal Cord Infarction : EDMIAS

Acronym: EDMIAS

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 4, 2020
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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