UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050750 |
|---|---|
| Receipt number | R000057806 |
| Scientific Title | Multicenter registry on gene polymorphism in cerebrovascular disease |
| Date of disclosure of the study information | 2023/04/15 |
| Last modified on | 2024/01/21 15:21:08 |
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Basic information
Public title
Multicenter registry on gene polymorphism in cerebrovascular disease
Acronym
NCVC Genome Registry
Scientific Title
Multicenter registry on gene polymorphism in cerebrovascular disease
Scientific Title:Acronym
NCVC Genome Registry
Region
| Japan |
Condition
Condition
Cerebrovascular disorders (cerebral infarction, transient ischemic attack, cerebral hemorrhage, asymptomatic extracranial/intracranial steno-occlusion, subarachnoid hemorrhage, cerebral arteriovenous malformation, dural arteriovenous fistula, venous sinus thrombosis, moyamoya disease, reversible cerebral vasospasm syndrome)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to elucidate the genetic predisposition to cerebrovascular diseases by conducting longitudinal studies.
Basic objectives2
Others
Basic objectives -Others
In this study, we aim to elucidate the genetic predisposition to cerebrovascular disease by a longitudinal study of the frequency and recurrence rate of gene polymorphisms associated with cerebrovascular disease (RNF213 p.R4810 and CYP2C19 PM) in each disease type in patients with cerebrovascular disease who were admitted or visited the National Cardiovascular Center or a collaborating research facility as outpatients. This study aims to elucidate the genetic predisposition to cerebrovascular diseases by conducting longitudinal studies.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence rate of ischemic events during the observation period
Key secondary outcomes
Incidence of bleeding events, all-cause mortality, and cardiovascular death during the observation period
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
Aged 20 years or older
Patients with cerebrovascular disease admitted to the institutes within 7 days from symptom onset or the last-known-well date
Patients with the provision of written informed consent for RNF213 p.R4810K genotyping examination and a comprehensive consent form for the NCVC Biobank
Key exclusion criteria
Patients deemed by the physician to be ineligible for participation in this study.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Ihara |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Neurology
Zip code
5648565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
0661701070
ihara@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshimoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Neurology
Zip code
5648565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
0661701070
Homepage URL
yoshimototakeshi1982@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Masafumi Ihara
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Neurology, Graduate School of Medicine, Mie University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
Tel
0661701070
rec-office-ac@ncvc.go.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
三重大学大学院医学研究科 神経病態内科学分野（三重県），京都府立医科大学医学系研究科 神経内科学（京都府），名古屋市立大学医学研究科 神経内科学分野（愛知県），武蔵野赤十字病院 神経内科（埼玉県），神戸市立医療センター中央市民病院（兵庫県），獨協医科大学埼玉医療センター（埼玉県），愛媛大学大学院医学研究科 脳神経外科学（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 15 | 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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 09 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are currently preparing to publish the results of the 5-year observation.
Management information
Registered date
| 2023 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057806
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