Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas (COPSDAVF) (COPSDAVF)
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|ClinicalTrials.gov Identifier: NCT03192800|
Recruitment Status : Unknown
Verified April 2018 by Hongqi Zhang, MD, Xuanwu Hospital, Beijing.
Recruitment status was: Recruiting
First Posted : June 20, 2017
Last Update Posted : April 23, 2018
|Condition or disease|
|Spinal Vascular Disorder Nos|
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|
|Estimated Enrollment :||300 participants|
|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|
- 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
- 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
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
|Contact: Yongjie MA, MD.||+86 firstname.lastname@example.org|
|Contact: Hongqi Zhang, PhD. MD.||+86 email@example.com|
|Neurosurgery Department of Xuanwu hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100053|
|Contact: Hongqi Zhang, PhD.,M.D +086 13601374152 firstname.lastname@example.org|
|Contact: Yongjie Ma, PhD.,M.D +086 15001388570 email@example.com|
|Principal Investigator: Hongqi Zhang, PhD.,M.D|
|Study Director:||Zhang Hongqi, MD.PHD.||Xuanwu Hospital, Beijing|