NCT00001364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 1993

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 1993

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
8.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 10, 2007

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

Spinal Arteriovenous MalformationsSpinal Dural Arteriovenous FistulasSurgeryEmbolizationSpinal Arteriography

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to tolerate MRI and/or spinal arteriography.
  • Child less than 4 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Oldfield EH, Doppman JL. Spinal arteriovenous malformations. Clin Neurosurg. 1988;34:161-83. No abstract available.

    PMID: 3288393BACKGROUND

MeSH Terms

Conditions

Arteriovenous FistulaArteriovenous MalformationsSpinal Cord Diseases

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

June 2, 1993

Study Completion

December 10, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-10

Locations