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NCT04372758: EDMIAS
Descriptive Study of Acute Spontaneous Spinal Cord Infarction
trial in Spinal Cord Infarction in 60 participants. Completed in 1 January 2021.
1 December 2020
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 30 May 2020 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 January 2021 |
| Sites | 1 location across France |
Conditions studied
- Spinal Cord Infarction — all drugs for Spinal Cord Infarction →
- Spinal Cord Stroke — all drugs for Spinal Cord Stroke →
- Vascular Myelopathy — all drugs for Vascular Myelopathy →
Sponsor
University Hospital, Montpellier
Who can join
18 and older, any sex, with Spinal Cord Infarction or Spinal Cord Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04372758
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04372758 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 11 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04372758.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing