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

April 21, 2021 updated by: Hongqi Zhang, MD

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hongqi Zhang, PhD. MD.
  • Phone Number: +86 13601374152
  • Email: hqzh@vip.163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Neurosurgery Department of Xuanwu hospital, Capital Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongqi Zhang, PhD.,M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 day before operation and 3 months, 6 months, 12 months postoperation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day before operation and 3 months, 6 months, 12 months postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongqi Zhang, MD

Collaborators

Beijing Haidian Hospital

Investigators

  • Study Director: Zhang Hongqi, MD.PHD., Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 18, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPSDAVF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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