UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006365 |
|---|---|
| Receipt number | R000007555 |
| Scientific Title | Prevalence of CCSVI (Chronic cerebrospinal venous insufficiency) in patients with multiple sclerosis, other central nervous system disorders, and healthy controls in Japan |
| Date of disclosure of the study information | 2011/09/17 |
| Last modified on | 2012/05/22 14:49:48 |
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Basic information
Public title
Prevalence of CCSVI (Chronic cerebrospinal venous insufficiency) in patients with multiple sclerosis, other central nervous system disorders, and healthy controls in Japan
Acronym
Prevalence of CCSVI (Chronic cerebrospinal venous insufficiency) in patients with multiple sclerosis, other central nervous system disorders, and healthy controls in Japan
Scientific Title
Prevalence of CCSVI (Chronic cerebrospinal venous insufficiency) in patients with multiple sclerosis, other central nervous system disorders, and healthy controls in Japan
Scientific Title:Acronym
Prevalence of CCSVI (Chronic cerebrospinal venous insufficiency) in patients with multiple sclerosis, other central nervous system disorders, and healthy controls in Japan
Region
| Japan |
Condition
Condition
multiple sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the prevalence of CCSVI in patients with multiple sclerosis, other CNS diseases, and healthy controls.
Basic objectives2
Others
Basic objectives -Others
prevalence rate
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
CCSVI prevalence(Zamboni's criteria)
Key secondary outcomes
CCSVI prevalence(CCSVI-Tokushukai' criteria
Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
ultrasonography
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.MS patients
Patients were diagnosed by the revised McDonald criteria
Phenotypes:not specified
EDSS score:1-5
2.Other central nervous system disease
3.Healthy adults
Men and women(composition ratio 1:3)
Key exclusion criteria
1. MS patients
The physician responsible for the study deems inappropriate
2.Other central nervous system disease
MS patients
The physician responsible for the study deems inappropriate
3.Healthy adults
MS patients
Other central nervous system disease
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Saito |
Organization
Shonan Kamakura General Hospital
Division name
Cardiology
Zip code
Address
1370-1,Okamoto,Kamakura-City,Kanagawa,Japan
TEL
0467-47-1717
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Saito |
Organization
Shonan Kamakura General Hospital
Division name
Cardiology
Zip code
Address
1370-1,Okamoto,Kamakura-City,Kanagawa,Japan
TEL
0467-47-1717
Homepage URL
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chigasaki Tokushukai Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湘南鎌倉総合病院（神奈川）
茅ヶ崎徳洲会総合病院（神奈川）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 17 | Day |
Last modified on
| 2012 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007555
