UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054287 |
|---|---|
| Receipt number | R000062002 |
| Scientific Title | Genome Registry and Stratification of Cardiovascular Disease Study: GRAND-STAR Next |
| Date of disclosure of the study information | 2024/05/05 |
| Last modified on | 2024/04/30 17:42:41 |
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Basic information
Public title
Genome Registry and Stratification of Cardiovascular Disease Study: GRAND-STAR Next
Acronym
GRAND-STAR Next
Scientific Title
Genome Registry and Stratification of Cardiovascular Disease Study: GRAND-STAR Next
Scientific Title:Acronym
GRAND-STAR Next
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Japanese individuals have a genetic background distinct from that of Western populations, necessitating a comprehensive database reflecting mutation information specifically relevant to the Japanese population. Japan has lacked a robust system for collecting and storing genetic data from patients with cardiovascular diseases suspected to have a genetic component. The research team, having conducted national registration studies of undiagnosed cardiovascular diseases, proposes to utilize their established techniques to create a nationwide genetic database by collecting genetic information on cardiovascular diseases from nationwide hospitals.
Basic objectives2
Others
Basic objectives -Others
This is and observational study and we will perform based on the objectives above.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploration of disease-related genes and genetic backgrounds through whole genome and whole exome sequencing analysis.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients with suspected hereditary cardiovascular diseases or those with cardiovascular diseases of unknown origin, along with their parents and other relatives.
(ii) Patients and others who have consented to the study, including genetic analysis, as detailed in the informed consent or opt-out method.
(iii) Patients who have consented to the use of samples or information from the National Cardiovascular Biobank.
Key exclusion criteria
(i) Patients who did not consent to the study.
Target sample size
5500
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Asano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Genomic Medicine
Zip code
564-8565
Address
6-1, Kishibe-Shimmachi, Suita, Osaka
TEL
06-6170-1069
asano.yoshihiro@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Asano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Genomic Medicine
Zip code
564-8565
Address
6-1, Kishibe-Shimmachi, Suita, Osaka
TEL
06-6170-1069
Homepage URL
asano.yoshihiro@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Intramural Research Fund for Cardiovascular Diseases of the National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, National Cerebral and Cardiovascular Center
Address
6-1, Kishibe-Shimmachi, Suita, Osaka
Tel
06-6170-1070
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062002
