Spinal Cord InfarctionEDMIASNCT04372758
Descriptive Study of Acute Spontaneous Spinal Cord Infarction
An observational study of Spinal Cord Infarction and Spinal Cord Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Infarction, Spinal Cord Stroke, Vascular Myelopathy
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2020to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All spontaneous SCI registered in medicine services from june 2010 to june 2020 in Montpellier University Hospital and Nîmes University Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study of Acute Spontaneous Spinal Cord Infarction : EDMIAS
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.
Read more
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.
- Keywords
- Neurology, Vascular disease, Paraplegia, Quadriplegia
- Medical subject headings
- Vascular Diseases, Paraplegia, Quadriplegia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
description of a recent spontaneous SCI cohort
description of patients diagnosed with spontaneous SCI
Measured: 1 day
Secondary outcomes (5)
evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies
evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies
Measured: 1 day
analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis
analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis
Measured: 1 day
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
Measured: 1 day
Retrospective evaluation of the potential candidates for IV thrombolysis
Retrospective evaluation of the potential candidates for IV thrombolysis
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start30 May 2020
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Nicolas Gaillard, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372758
- Sponsor's protocol ID
- RECHMPL20_0245
- Acronym
- EDMIAS
- Status last verified
- May 2021
- First submitted
- 29 Apr 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Acute Spontaneous Spinal Cord Infarction : EDMIAS
- ClinicalTrials.gov ID
- NCT04372758
- Acronym / sponsor ID
- EDMIAS / RECHMPL20_0245
- Keywords
- Neurology, Vascular disease, Paraplegia, Quadriplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Study start
- 30 May 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All spontaneous SCI registered in medicine services from june 2010 to june 2020 in Montpellier University Hospital and Nîmes University Hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
description of a recent spontaneous SCI cohort
Time frame: 1 day
description of patients diagnosed with spontaneous SCI
5 secondary outcomes
evaluation of JAMA 2019 diagnostic criteria in spontaneous SCI and other myelopathies
Time frame: 1 day
analysis of relevant clinical and radiological criteria for positive diagnosis and prognosis
Time frame: 1 day
Description of clinico-radiological territories, etiology and physiopathology of spontaneous SCI, including application of fibrocartilaginous embolism criteria 2015
Time frame: 1 day
Retrospective evaluation of the potential candidates for IV thrombolysis
Time frame: 1 day
Evaluation of relevant criteria in order to create a prospective multicentric cohort of spontaneous SCI.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Gaillard, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Infarction and Spinal Cord Stroke, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of a recent spontaneous SCI cohort (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.