UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026671 |
|---|---|
| Receipt number | 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 | 2024/03/28 18:04:30 |
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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 | Kazuo |
| Middle name | |
| Last name | Kitagawa |
Organization
Tokyo Women's Medical Univeristy
Division name
Department of Neurology
Zip code
1628666
Address
8-1 Kawada-cho Shinjuku-ku Tokyo
TEL
0333538111
kitagawa.kazuo@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Kitagawa |
Organization
Tokyo Women's Medical University
Division name
Department of Neurology
Zip code
1628666
Address
Shinjuku-ku
TEL
0333538111
Homepage URL
kitagawa.kazuo@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical Univeristy
Institute
Department
Personal name
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
Clinical Research Center, Tokyo Women's Medical University Hospital
Address
8-1 Kawada-cho Shinjuku-ku Tokyo
Tel
0333538111
riniri.bm@twmu.ac.jp
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
Hypertens Res. 2023 May;46(5):1326-1334. doi: 10.1038/s41440-023-01244-8.
Publication of results
Published
Result
URL related to results and publications
Hypertens Res. 2023 May;46(5):1326-1334. doi: 10.1038/s41440-023-01244-8.
Number of participants that the trial has enrolled
1005
Results
Both total and modified Small nessel disease score : SVD scores were significantly associated with MMSE and MoCA-J scores. After adjustment for age, sex, education, risk factors, and medial temporal atrophy, the association between the modified SVD score and global cognitive scores remained significant. The modified SVD score was independently associated with attention.
Results date posted
| 2024 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Outpatients aged 40 years with any vascular risk factors or a history of cerebrovascular events who underwent brain magnetic resonance imaging (MRI) within 1 year and had any signs of cerebral vessel disease.
Participant flow
Among patients enrolled in the TWMU CVD registry, 64 refused to undergo cognitive examination, 234 did not undergo T2* imaging, and 76 had a MMSE score <24 ). After exclusion of 374 patients, 648 patients who underwent MRI examination, including T2*, and both MMSE and MoCA-J examinations, were analyzed.
Adverse events
None
Outcome measures
Global cognitive function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | 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
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030620
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