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Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas (COPSDAVF) (COPSDAVF)

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ClinicalTrials.gov Identifier: NCT03192800
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Beijing Haidian Hospital
Information provided by (Responsible Party):
Hongqi Zhang, MD, Xuanwu Hospital, Beijing

Brief 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. 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.

Condition or disease
Spinal Vascular Disorder Nos

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Modified Denis Pain and Numbness Scale (mDPNS) [ Time Frame: 1 day before operation and 3 months, 6 months, 12 months postoperation ]
    mDPNS for evaluating the sensory function of patients with SDAVFs before and after operations



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192800


Contacts
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Contact: Yongjie MA, MD. +86 15001388570 mayongjiedocotr@sina.com
Contact: Hongqi Zhang, PhD. MD. +86 13601374152 hqzh@vip.163.com

Locations
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China, Beijing
Neurosurgery Department of Xuanwu hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Hongqi Zhang, PhD.,M.D    +086 13601374152    xwzhanghq@163.com   
Contact: Yongjie Ma, PhD.,M.D    +086 15001388570    mayongjiedoctor@sina.com   
Principal Investigator: Hongqi Zhang, PhD.,M.D         
Sponsors and Collaborators
Hongqi Zhang, MD
Beijing Haidian Hospital
Investigators
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Study Director: Zhang Hongqi, MD.PHD. Xuanwu Hospital, Beijing

Publications of Results:
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Responsible Party: Hongqi Zhang, MD, Director, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03192800     History of Changes
Other Study ID Numbers: COPSDAVF
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hongqi Zhang, MD, Xuanwu Hospital, Beijing:
clinical outcome
prognositic factor
spinal dural arteriovenous fistula

Additional relevant MeSH terms:
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Central Nervous System Vascular Malformations
Arteriovenous Fistula
Vascular Diseases
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Congenital Abnormalities
Nervous System Malformations
Nervous System Diseases