Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001364
First received: November 3, 1999
Last updated: March 5, 2008
Last verified: December 2007
  Purpose

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.


Condition
Arteriovenous Fistula
Arteriovenous Malformation
Spinal Cord Disease

Study Type: Observational
Official Title: Evaluation and Treatment of Patients With Spinal Vascular Abnormalities

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: June 1993
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001364

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001364     History of Changes
Other Study ID Numbers: 930151, 93-N-0151
Study First Received: November 3, 1999
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Spinal Arteriovenous Malformations
Spinal Dural Arteriovenous Fistulas
Surgery
Embolization
Spinal Arteriography

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Spinal Cord Diseases
Pathological Conditions, Anatomical
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014