UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054758 |
|---|---|
| Receipt number | R000062284 |
| Scientific Title | A prospective observational study on the association between genetic factors and cerebral small vessel disease in Healthy Adults: The Kashima Scan Study-2 |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/11 08:35:03 |
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Basic information
Public title
A prospective observational study on the association between genetic factors and cerebral small vessel disease in Healthy Adults: The Kashima Scan Study-2
Acronym
KSS-2
Scientific Title
A prospective observational study on the association between genetic factors and cerebral small vessel disease in Healthy Adults: The Kashima Scan Study-2
Scientific Title:Acronym
KSS-2
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the association between genetic factors and cerebral small vessel disease and prognosis in healthy adults.
Basic objectives2
Others
Basic objectives -Others
Risk assessment of cerebral small vessel disease, cerebro-cardiovascular events, cognitive impairment, and death associated with the ALDH2, ADH1B, and APOE genotypes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebro-cardiovascular events and death
Key secondary outcomes
cognitive impairment
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. individuals who underwent health screening test involving cranial MRI at Yuai-Kai Oda Hospital between September 1, 2018 and December 31, 2024
2. individuals with no disability in instrumental activities of daily living
3. individuals who can give written informed consent
Key exclusion criteria
1. individuals with inability to undergo brain MRI
2. individuals with a history of traumatic brain injury or neurological disorders
3. individuals with a history of ischemic heart disease
4. individuals who present with neurological abnormalities at the examination.
Target sample size
850
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yakushiji |
Organization
Kansai Medical Universiy
Division name
Department of Neurology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata 573-1010, Japan
TEL
072-804-2540
yakushiy@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Yakushiji |
Organization
Kansai Medical University
Division name
Department of Neurology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata 573-1010, Japan
TEL
072-804-2540
Homepage URL
yakushiy@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review boards of Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata 573-1010, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | 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
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects will be followed up annually through questionnaires to obtain information about cerebro-cardiovascular events and all-cause mortality.
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062284
