The purpose of this study is clinical outcome evaluation of endovascular embolization for the treatment of spinal AVMs. In this clinical trial, patients will be recruited from radiologic center, Imam Khomeini Hospital, Tehran University of Medical Sciences (TUMS), Tehran, Iran. After definitive diagnosis of spinal AVMs based on spinal-MRI/angiography, functional status and tumor size will be measured by use of the Aminoff Logue Disability Scale and spinal MRI, respectively. Then endovascular embolization will be performed. After 6 months, clinical outcome will be evaluated with Logue Disability Scale and spinal MRI again. Primary outcome measure is clinical outcome of endovascular embolization for the treatment of spinal AVMs. Secondary outcome measure is change in tumor size after endovascular embolization.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014071218457N1
Registration date:2014-12-02, 1393/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-02, 1393/09/11
Registrant information
Name
Hossein Ghanaati
Name of organization / entity
Advanced Diagnostic and Interventional Radiology Research Center (ADIR), Tehran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1516
Email address
ghenaati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences (TUMS)
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical outcomes of endovascular embolization for the treatment of Spinal ArterioVenous Malformations (AVMs)
Public title
Clinical outcomes of endovascular embolization for the treatment of Spinal ArterioVenous Malformations (AVMs)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with spinal AVMs diagnosis
Exclusion criteria: Patients under 10 years; Previous surgery for the treatment of AVMs; Allergic reaction to contrast material
Age
From 10 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Tehran University of Medical Sciences
Street address
Ghods Avenue, Keshavarz Blvd.
City
Tehran
Postal code
1419733141
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
92-03-98-24546-108289
Health conditions studied
1
Description of health condition studied
Spinal Arterio-Venous Malformation
ICD-10 code
C72.0
ICD-10 code description
Spinal cord
Primary outcomes
1
Description
Walking, Muscle force, Urinary incontinence
Timepoint
After 6 months
Method of measurement
Aminoff Logue scale
Secondary outcomes
1
Description
Tumor size
Timepoint
6 months
Method of measurement
Spinal MRI
Intervention groups
1
Description
ٍEndovascular embolization; after catheterization of the tumor feeder artery, Onyx will be injected throughout the catheter.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Imaging Center, Imam Khomeini Hospital, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Hossein Ghanaati
Street address
Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Imam Khomeini Hospital, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Masoud Younesian
Street address
Keshavarz Blvd.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Imam Khomeini Hospital, Tehran University of Medical Sciences (TUMS)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medical Imaging Center, Imam Khomeini Hospital, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Hossein Ghanaati
Position
Professor, Interventional Radiologist
Other areas of specialty/work
Street address
Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2670
Fax
+98 21 6658 1578
Email
ghanaati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Imaging Center, Imam Khomeini Hospital, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Hossein Ghanaati
Position
Professor, Interventional Radiologist
Other areas of specialty/work
Street address
Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2670
Fax
Email
ghanaati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Imaging Center, Imam Khomeini Hospital, Tehran University of Medical Sciences (TUMS
Full name of responsible person
Arya Haj Mirzaian
Position
General Physician
Other areas of specialty/work
Street address
Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2670
Fax
Email
arya.mirzaian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)