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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name