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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name