UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020593
Receipt No. 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 2016/01/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name AIBA Takeshi
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita
TEL 06-6833-5012
Email aiba@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name AIBA, Takeshi
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita
TEL 06-6833-5012
Homepage URL
Email aiba@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardioascular Center
Institute
Department

Funding Source
Organization the Ministry of Health, Labour, and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Niigata University,
Keio University,
Tokyo Womens Medical University
Nippon Medical School
Riken Institute
Kanazawa University
Shiga Univ. School of Medical Science
Kyoto University
Okayama University
Nagasaki University
Kamoshima University

Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2000 Year 12 Month 01 Day
Last follow-up date
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 from 2001 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
2016 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.