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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026671
Receipt No. R000030620
Scientific Title Prospective study for patients with cerebral vessel disease in Tokyo Women's Medical Univeristy
Date of disclosure of the study information 2017/04/01
Last modified on 2017/03/23

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Basic information
Public title Prospective study for patients with cerebral vessel disease in Tokyo Women's Medical Univeristy
Acronym TWMU CVD Registry
Scientific Title Prospective study for patients with cerebral vessel disease in Tokyo Women's Medical Univeristy
Scientific Title:Acronym TWMU CVD Registry
Region
Japan

Condition
Condition Cerebrovascular Disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the factors associated with stroke, cognitive impairment, motor and gait disturbance, urinary incontinence, dysphagia and mood disorders in patients with cerebral vessel disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Stroke, Vascular events, death, dementia, Parkinsonism, ADL, urinary incontinence,
aspiration peumonia, depression (every 3 year up to 6 year)
Key secondary outcomes Brain MRI, carotid ultrasound, cognitive function, gait function, motor function (UPDRS Part III), apathy scale, SDS depression scale, urinary function (measurement of liquid in the bladder), motor and sensory evoked potential, flow-mediated vasodilation, transcranial doppler for cerebrovascular reserve (every 3 year up to six year)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Any cerebral vessel disease in brain MRI within 1 year
2. Independence of ADL
3. Written informed consent
4. Scheduled visiting to our department
Key exclusion criteria 1. A history of neurodegenerative disease, neuroimmunology disease, neuroinfection
2. Alcohol toxication, Drug toxication
3. Dementia
4. Other any reasons judged from principle investigator
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kitagawa Kazuo
Organization Tokyo Women's Medical Univeristy
Division name Department of Neurology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666
TEL 03-3353-8111
Email kitagawa.kazuo@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kitagawa Kazuo
Organization Tokyo Women's Medical Univeristy
Division name Department of Neurology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666
TEL 03-3353-8111
Homepage URL http://www.twmu.ac.jp/neurology/
Email kitagawa.kazuo@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical Univeristy
Institute
Department

Funding Source
Organization Tokyo Women's Medical Univeristy
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 東京女子医科大学

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 06 Month 30 Day
Date analysis concluded
2023 Year 09 Month 30 Day

Other
Other related information Follow-up in every three years for brain MRI, carotid ultrasound, cognitive function, gait function, swallowing, UPDRS and bladder function

Management information
Registered date
2017 Year 03 Month 23 Day
Last modified on
2017 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030620

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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