UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053039 |
|---|---|
| Receipt number | R000060446 |
| Scientific Title | Validation of the prevalence of RNF213 variants in patients with non-obstructive coronary artery disease (INOCA) for precision medicine and creation of a polygenic risk score model for the development of INOCA. |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2024/12/16 13:41:19 |
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Basic information
Public title
Validation of the prevalence of RNF213 variants in patients with non-obstructive coronary artery disease (INOCA) for precision medicine and creation of a polygenic risk score model for the development of INOCA.
Acronym
Validation of the prevalence of RNF213 variants in patients with non-obstructive coronary artery disease (INOCA) for precision medicine and creation of a polygenic risk score model for the development of INOCA.
Scientific Title
Validation of the prevalence of RNF213 variants in patients with non-obstructive coronary artery disease (INOCA) for precision medicine and creation of a polygenic risk score model for the development of INOCA.
Scientific Title:Acronym
Validation of the prevalence of RNF213 variants in patients with non-obstructive coronary artery disease (INOCA) for precision medicine and creation of a polygenic risk score model for the development of INOCA.
Region
| Japan |
Condition
Condition
coronary artery disease (including coronary spastic angina, and coronary microvascular dysfunction)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The RNF213 gene polymorphism, which has been reported to be associated with Moyamoya disease, is suggested to be linked to atherosclerotic cerebral infarction and coronary spastic angina. This study aims to investigate the prevalence of the RNF213 gene polymorphism in non-obstructive coronary artery disease and clarify the clinical characteristics and prognosis of individuals with and without the polymorphism. The further objective is to create of a polygenic risk score model for the development of INOCA.
Basic objectives2
Others
Basic objectives -Others
Determination of polygenic risk in non-obstructive coronary artery disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A polygenic risk score model for the development of INOCA
Key secondary outcomes
The prevalence of RNF213 variants, Prognosis, Therapeutic resistance, Rehospitalization, Vasoreactivity
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
Non-obstructive coronary artery disease
Key exclusion criteria
Patients deemed inappropriate for participation in this study by the researcher
Patients who declined the use of information for research
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Noguchi |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular department
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
0661701070
tnoguchi@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Teruo |
| Middle name | |
| Last name | Noguchi |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular department
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
0661701070
Homepage URL
tnoguchi@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee
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
熊本大学病院(熊本県)、東北大学病院(宮城県)、獨協医科大学病院(栃木県)、近森病院(高知県)、飯塚病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 11 | 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
Clinical data were electronically collected using the REDCap (Research Electronic Data Capture) system to construct and manage case databases at each institution.
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to investigate the clinical characteristics based on RNF213 gene polymorphism in patients with non-obstructive coronary artery disease (INOCA), and to create a polygenic risk score model associated with the development of INOCA.
Management information
Registered date
| 2023 | Year | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060446
