Spinal Vascular Disorder NosCOPSDAVFNCT03192800
Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas (COPSDAVF)
An observational study of Spinal Vascular Disorder Nos, run by Hongqi Zhang, MD at 1 site in China.
Trial summary
Spinal dural arteriovenous fistulas (SDAVFs) are the most common vascular disorder of the spine and account for approximately 70% of spinal vascular malformation.They are a rare pathology with an excepted incidence of only 5-10 new cases per million inhabitants per year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Vascular Disorder Nos
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2013to 31 Mar 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with spinal dural arteriovenous fistulas admitted to department of neurosurgery in Xuanwu Hospital and department of neurosurgery in Beijing Haidian Hospital.
Who may be able to join
- patient diagnosed with spinal dural arteriovenous fiatulas
- the fiatula locate between C2 and L5
- patient not received surgical or interventional treatment before
- patient with normal cardiac, renal and hepatic function
- patient capable of understanding the content of the patient information / Informed Consent Form
- patient willing and able to participate in the registry
Who cannot join
- patient received surgical treatment or interventional treatment before
- patient is pregnant patient allergic to iodine
- patient unable to complete follow-up
- patient with cerebral lesions patient with other spinal lesions
- patient with cardiac, renal or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Neurosurgery Department of Xuanwu hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Hongqi Zhang, PhD.,M.D, +086 13601374152, xwzhanghq@163.com
Yongjie Ma, PhD.,M.D, +086 15001388570, mayongjiedoctor@sina.com
About this study
Official title: Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas
Spinal dural arteriovenous fistulas (SDAVFs) are the most common vascular disorder of the spine and account for approximately 70% of spinal vascular malformation.They are a rare pathology with an excepted incidence of only 5-10 new cases per million inhabitants per year. Most fistulas are found in the thoracolumbar region and > 80% of all SDAVFs are located between T6 and L2, whereas the cranio-cervical, cervical and sacral fistulas are more rare. SDAVFs have an overwhelmingly male predominance (80%), with an age presentation in the fifth or sixth dacede. It is presumed that SDAVFs are acquired diseases. A typical SDAVF is located inside the dural mater close to nerve root. It is fed by a radiculomeningeal artery and enters a radicular vein that merges in the perimedullary plexus. The presence of a shunt leads to a reversal of blood flow to the spinal cord venous system, which then induces venous hypertensive myelopathy.
Read the detailed description
The initial symptoms of venous congestion include gait disturbances, sensory symptoms (hyperesthesia and paresthesia), and sphincter dysfunction. These neurological symptoms are unspecific, so SDAVFs often go clinically underdiagnosed or misdiagnosed. But SDAVFs typically demonstrated a characteristic imaging appearance on spinal MRI including multilevel centromedullary cord T2 hyperintensity, enlarged intradural vessels along the dorsal and ventral aspect of the cord. If an SDAVF is suspected, conventional spinal angiography is required to confirm the diagnosis and determine the location of the fistula. Flowing diagnosis, expedient treatment is required, both microsurgery and endovascular embolization are safe and can achieve complete occlusion, the progression of the neurological deficits can be stopped in most instances.
However, it is difficult to predict whose symptoms will improve and whose will stabilize or deteriorate. Due to the low incidence of the SDAVFs, nearly all studies which have been published about the clinical outcome and prognostic factors of SDAVFs are relatively limited and most of them are retrospective. In these studies, the preoperative severity of disability, age, gender, location of fistula and duration of symptoms have been analyzed as prognostic factors, therefore it remains unclear which are the most reliable predictor of clinical outcome. Moreover, the conclusions may be biased by long span of follow-up period or few clinical cases. Besides, the fitulas at the craniocervical junction often present with hemorrhage, while those below conus constitute 3 types of lesions. So the invsetigator conduct this prospective cohort study to clarify the 1-year outcome of patients with cervical and thoracolumbar SDAVFs and to determine the main prognostic factors.
- Conditions
- Spinal Vascular Disorder Nos
- Keywords
- clinical outcome, prognositic factor, spinal dural arteriovenous fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the spinal cord function
Modified Aminoff \& Logue's Scale for evaluating the spinal cord function
Measured: 1 day before operation and 3 months, 6 months, 12 months postoperation
Secondary outcomes (1)
Modified Denis Pain and Numbness Scale (mDPNS)
mDPNS for evaluating the sensory function of patients with SDAVFs before and after operations
Measured: 1 day before operation and 3 months, 6 months, 12 months postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Mar 2013
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal Vascular Disorder NosStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongqi Zhang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Responsible party
- Sponsor-investigator, Hongqi Zhang, MD, Xuanwu Hospital, Beijing
- Investigators
- Zhang Hongqi, MD.PHD., Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192800
- Sponsor's protocol ID
- COPSDAVF
- Acronym
- COPSDAVF
- Status last verified
- Apr 2021
- First submitted
- 14 Jun 2017
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cenzato M, Versari P, Righi C, Simionato F, Casali C, Giovanelli M. Spinal dural arteriovenous fistulae: analysis of outcome in relation to pretreatment indicators. Neurosurgery. 2004 Oct;55(4):815-22; discussion 822-3. doi: 10.1227/01.neu.0000137630.50959.a7.
PubMed 15458589Steinmetz MP, Chow MM, Krishnaney AA, Andrews-Hinders D, Benzel EC, Masaryk TJ, Mayberg MR, Rasmussen PA. Outcome after the treatment of spinal dural arteriovenous fistulae: a contemporary single-institution series and meta-analysis. Neurosurgery. 2004 Jul;55(1):77-87; discussion 87-8. doi: 10.1227/01.neu.0000126878.95006.0f.
PubMed 15214976Fugate JE, Lanzino G, Rabinstein AA. Clinical presentation and prognostic factors of spinal dural arteriovenous fistulas: an overview. Neurosurg Focus. 2012 May;32(5):E17. doi: 10.3171/2012.1.FOCUS11376.
PubMed 22537126Sherif C, Gruber A, Bavinzski G, Standhardt H, Widhalm G, Gibson D, Richling B, Knosp E. Long-term outcome of a multidisciplinary concept of spinal dural arteriovenous fistulae treatment. Neuroradiology. 2008 Jan;50(1):67-74. doi: 10.1007/s00234-007-0303-4. Epub 2007 Nov 20.
PubMed 18026943Saladino A, Atkinson JL, Rabinstein AA, Piepgras DG, Marsh WR, Krauss WE, Kaufmann TJ, Lanzino G. Surgical treatment of spinal dural arteriovenous fistulae: a consecutive series of 154 patients. Neurosurgery. 2010 Nov;67(5):1350-7; discussion 1357-8. doi: 10.1227/NEU.0b013e3181ef2821.
PubMed 20871454Krings T, Geibprasert S. Spinal dural arteriovenous fistulas. AJNR Am J Neuroradiol. 2009 Apr;30(4):639-48. doi: 10.3174/ajnr.A1485. Epub 2009 Feb 12.
PubMed 19213818
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas
- ClinicalTrials.gov ID
- NCT03192800
- Acronym / sponsor ID
- COPSDAVF / COPSDAVF
- Conditions
- Spinal Vascular Disorder Nos
- Keywords
- clinical outcome, prognositic factor, spinal dural arteriovenous fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hongqi Zhang, MDUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 20 Jun 2017 (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.
Spinal dural arteriovenous fistulas (SDAVFs) are the most common vascular disorder of the spine and account for approximately 70% of spinal vascular malformation.They are a rare pathology with an excepted incidence of only 5-10 new cases per million inhabitants per year. Most fistulas are found in the thoracolumbar region and > 80% of all SDAVFs are located between T6 and L2, whereas the cranio-cervical, cervical and sacral fistulas are more rare. SDAVFs have an overwhelmingly male predominance (80%), with an age presentation in the fifth or sixth dacede. It is presumed that SDAVFs are acquired diseases. A typical SDAVF is located inside the dural mater close to nerve root. It is fed by a radiculomeningeal artery and enters a radicular vein that merges in the perimedullary plexus. The presence of a shunt leads to a reversal of blood flow to the spinal cord venous system, which then induces venous hypertensive myelopathy.
Detailed description
The initial symptoms of venous congestion include gait disturbances, sensory symptoms (hyperesthesia and paresthesia), and sphincter dysfunction. These neurological symptoms are unspecific, so SDAVFs often go clinically underdiagnosed or misdiagnosed. But SDAVFs typically demonstrated a characteristic imaging appearance on spinal MRI including multilevel centromedullary cord T2 hyperintensity, enlarged intradural vessels along the dorsal and ventral aspect of the cord. If an SDAVF is suspected, conventional spinal angiography is required to confirm the diagnosis and determine the location of the fistula. Flowing diagnosis, expedient treatment is required, both microsurgery and endovascular embolization are safe and can achieve complete occlusion, the progression of the neurological deficits can be stopped in most instances.
However, it is difficult to predict whose symptoms will improve and whose will stabilize or deteriorate. Due to the low incidence of the SDAVFs, nearly all studies which have been published about the clinical outcome and prognostic factors of SDAVFs are relatively limited and most of them are retrospective. In these studies, the preoperative severity of disability, age, gender, location of fistula and duration of symptoms have been analyzed as prognostic factors, therefore it remains unclear which are the most reliable predictor of clinical outcome. Moreover, the conclusions may be biased by long span of follow-up period or few clinical cases. Besides, the fitulas at the craniocervical junction often present with hemorrhage, while those below conus constitute 3 types of lesions. So the invsetigator conduct this prospective cohort study to clarify the 1-year outcome of patients with cervical and thoracolumbar SDAVFs and to determine the main prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with spinal dural arteriovenous fistulas admitted to department of neurosurgery in Xuanwu Hospital and department of neurosurgery in Beijing Haidian Hospital.
Key inclusion criteria (6 listed)
- patient diagnosed with spinal dural arteriovenous fiatulas
- the fiatula locate between C2 and L5
- patient not received surgical or interventional treatment before
- patient with normal cardiac, renal and hepatic function
- patient capable of understanding the content of the patient information / Informed Consent Form
Key exclusion criteria (5 listed)
- patient received surgical treatment or interventional treatment before
- patient is pregnant patient allergic to iodine
- patient unable to complete follow-up
- patient with cerebral lesions patient with other spinal lesions
- patient with cardiac, renal or hepatic dysfunction
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
Change of the spinal cord function
Time frame: 1 day before operation and 3 months, 6 months, 12 months postoperation
Modified Aminoff \& Logue's Scale for evaluating the spinal cord function
1 secondary outcome
Modified Denis Pain and Numbness Scale (mDPNS)
Time frame: 1 day before operation and 3 months, 6 months, 12 months postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Results publication: PubMed 15458589Cenzato M, Versari P, Righi C, Simionato F, Casali C, Giovanelli M. Spinal dural arteriovenous fistulae: analysis of outcome in relation to pretreatment indicators. Neurosurgery. 2004 Oct;55(4):815-22; discussion 822-3. doi: 10.1227/01.neu.0000137630.50959.a7.
- Results publication: PubMed 15214976Steinmetz MP, Chow MM, Krishnaney AA, Andrews-Hinders D, Benzel EC, Masaryk TJ, Mayberg MR, Rasmussen PA. Outcome after the treatment of spinal dural arteriovenous fistulae: a contemporary single-institution series and meta-analysis. Neurosurgery. 2004 Jul;55(1):77-87; discussion 87-8. doi: 10.1227/01.neu.0000126878.95006.0f.
- Results publication: PubMed 22537126Fugate JE, Lanzino G, Rabinstein AA. Clinical presentation and prognostic factors of spinal dural arteriovenous fistulas: an overview. Neurosurg Focus. 2012 May;32(5):E17. doi: 10.3171/2012.1.FOCUS11376.
- Results publication: PubMed 18026943Sherif C, Gruber A, Bavinzski G, Standhardt H, Widhalm G, Gibson D, Richling B, Knosp E. Long-term outcome of a multidisciplinary concept of spinal dural arteriovenous fistulae treatment. Neuroradiology. 2008 Jan;50(1):67-74. doi: 10.1007/s00234-007-0303-4. Epub 2007 Nov 20.
- Results publication: PubMed 20871454Saladino A, Atkinson JL, Rabinstein AA, Piepgras DG, Marsh WR, Krauss WE, Kaufmann TJ, Lanzino G. Surgical treatment of spinal dural arteriovenous fistulae: a consecutive series of 154 patients. Neurosurgery. 2010 Nov;67(5):1350-7; discussion 1357-8. doi: 10.1227/NEU.0b013e3181ef2821.
- Results publication: PubMed 19213818Krings T, Geibprasert S. Spinal dural arteriovenous fistulas. AJNR Am J Neuroradiol. 2009 Apr;30(4):639-48. doi: 10.3174/ajnr.A1485. Epub 2009 Feb 12.
- Individual participant dataSharing planned: Undecided
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.
Zhang Hongqi, MD.PHD. study director
Xuanwu Hospital, Beijing
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 Vascular Disorder Nos, run by Hongqi Zhang, MD at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjie MA, MD. (+86 15001388570, mayongjiedocotr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the spinal cord function (time frame: 1 day before operation and 3 months, 6 months, 12 months postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192800, which also lists 6 linked publications.
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 22 Apr 2021.