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Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities

Primary Purpose

Arteriovenous Fistula, Arteriovenous Malformation, Spinal Cord Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Arteriovenous Fistula focused on measuring Spinal Arteriovenous Malformations, Spinal Dural Arteriovenous Fistulas, Surgery, Embolization, Spinal Arteriography

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Adult greater than or equal to 18 years with known or suspected spinal AVM and capacity to provide written informed consent. Child ages 4-18 with known or suspected spinal AVM and with parent/guardian informed consent. EXCLUSION CRITERIA: Unable to tolerate MRI and/or spinal arteriography. Child less than 4 years.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001364
Brief Title
Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities
Official Title
Evaluation and Treatment of Patients With Spinal Vascular Abnormalities
Study Type
Observational

2. Study Status

Record Verification Date
December 10, 2007
Overall Recruitment Status
Completed
Study Start Date
June 2, 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 10, 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
Arteriovenous malformations (AVM) are abnormally formed blood vessels that can be located throughout the brain and spinal cord. Patients with abnormalities of the blood vessels located in and around the spinal cord can develop many neurological problems. Some problems include, weakness, pain, difficulty walking, paralysis, and even death. The treatment for these AVMs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. The treatment is aimed at stopping the neurologic problems from worsening and possibly correcting the existing problems. There are two commonly used treatments for AVMs, surgery and embolization (blocking off of blood flow to the AVM). However, researchers have limited experience treating these conditions because they are rare. In addition, it has been difficult to classify different kinds of AVMs and to develop new treatments for them. This study is designed to increase researchers understanding of AVMs by admitting and following patients diagnosed with the condition. By increasing the amount of patients studied diagnosed with spinal blood vessel abnormalities, researchers can begin to develop new management plans for patients with AVMs.
Detailed Description
Spinal Arteriovenous Malformations are rare lesions that frequently effect young patients and adults in their most productive years. They cause progressive myelopathy, ultimately causing paraplegia or quadriplegia if untreated. Because they are rare lesions, experience with treating them in sufficient numbers to permit classification of them, investigation of the pathophysiology of myelopathy, and the introduction of new techniques for treatment has been possible in only a very few centers in this country. One essential element of investigation of them is selective spinal arteriography. Since selective spinal arteriography was first introduced for these lesions here at the NIH in the mid 1960's by Drs. John Doppman and Giovanni DiChiro, the NIH has been such a center of expertise for patients with spinal arteriovenous malformations. Because of this, NIH has been, and is, a national referral center for these patients. However, there has never been an approved protocol at the NIH for investigation or treatment of these patients. The purpose of this proposal is to present a plan of investigation and treatment which will serve as a protocol under which to admit these patients and to permit continued accrual of clinical experience with them that will serve to guide others in the management of these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula, Arteriovenous Malformation, Spinal Cord Disease
Keywords
Spinal Arteriovenous Malformations, Spinal Dural Arteriovenous Fistulas, Surgery, Embolization, Spinal Arteriography

7. Study Design

Enrollment
120 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Adult greater than or equal to 18 years with known or suspected spinal AVM and capacity to provide written informed consent. Child ages 4-18 with known or suspected spinal AVM and with parent/guardian informed consent. EXCLUSION CRITERIA: Unable to tolerate MRI and/or spinal arteriography. Child less than 4 years.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3288393
Citation
Oldfield EH, Doppman JL. Spinal arteriovenous malformations. Clin Neurosurg. 1988;34:161-83. No abstract available.
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Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities

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