UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020593 |
|---|---|
| Receipt number | R000023772 |
| Scientific Title | Clinical and Genetic Features of Japanese Families with Inherited Arrhythmias: A Multicenter-Registry Study |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2023/07/14 13:01:48 |
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Basic information
Public title
Clinical and Genetic Features of Japanese Families with Inherited Arrhythmias: A Multicenter-Registry Study
Acronym
Japanese Multicenter-registry Study for The inherited arrhythmias (J-MYSTERY)
Scientific Title
Clinical and Genetic Features of Japanese Families with Inherited Arrhythmias: A Multicenter-Registry Study
Scientific Title:Acronym
Japanese Multicenter-registry Study for The inherited arrhythmias (J-MYSTERY)
Region
| Japan |
Condition
Condition
All inherited (familial) arrhythmias, such as congenital or acquired long-QT syndrome, Brugada syndrome, idiopathic VF, PCCD, familial bradicardia syndrome including AF, CPVT, short-QT syndrome, ARVC or other cardiomyopathy (including laminopathy, HCM and DCM).
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
(1)Genetic diagnosis, (2) Genotype and Phenotype correlation analysis for the personalized medicine, (3) Exome sequencing or whole gene analysis for the new disease mechanisms
Basic objectives2
Others
Basic objectives -Others
Genetic and clinical features of arrhythmic diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the disease-causing genes and mutations
Key secondary outcomes
Genetic-based personalized medicine
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
Patients or their family members in the several inherited arrhythmias such as LQTS, Brugada syndrome, Idiopathic VF, PCCD, familial SSS, AVB, AF, CPVT, short QT syndrome, cardiomyopathy (ARVC, laminopathy) etc.
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | AIBA |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita
TEL
06-6170-1070
aiba@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | AIBA |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
5-7-1 Fujishiro-dai, Suita
TEL
06-6833-5012
Homepage URL
aiba@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardioascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center, Research grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Niigata University
Tsukuba University
Saitama Medical University
Kanazawa University
Shiga Univ. School of Medical Science
Kyoto University
Okayama University
Kagoshima Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Shimmachi Suita Osaka
Tel
+81661701070
aiba@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
| 2016 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2000 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort Study.
Inclusion criteria:
Patients or families who had a inherited arrhythmia (LQTS, Brugada syndrome, Idiopathic VF, PCCD, familial SSS, CPVT, SQTS, Cardiomyopathy such as Laminopathy or ARVC etc) and had been investigated the genetic and clinical features regardless of age. If patients or subjects are younger than 16 years old, agreement of paerson in parental authority is necessary.
Management information
Registered date
| 2016 | Year | 01 | Month | 16 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023772
