UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039734
Receipt number R000045316
Scientific Title Construction of a genetic diagnosis system for cardiovascular diseases based on abnormalities of myocardium, connective tissue and vascular wall
Date of disclosure of the study information 2020/03/07
Last modified on 2020/03/07 17:15:24

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Basic information

Public title

Construction of a genetic diagnosis system for cardiovascular diseases based on abnormalities of myocardium, connective tissue and vascular wall

Acronym

Construction of a genetic diagnosis system for cardiovascular diseases based on abnormalities of myocardium, connective tissue and vascular wall

Scientific Title

Construction of a genetic diagnosis system for cardiovascular diseases based on abnormalities of myocardium, connective tissue and vascular wall

Scientific Title:Acronym

Construction of a genetic diagnosis system for cardiovascular diseases based on abnormalities of myocardium, connective tissue and vascular wall

Region

Japan


Condition

Condition

Cardiovascular disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Construction of genetic diagnosis system

Basic objectives2

Others

Basic objectives -Others


Search for causative genes

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Construction of genetic diagnosis system

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

Patients with congenital disease and their parents / brothers who have abnormalities in myocardial / vascular walls and connective tissue at the Cardiology Department of International University of Health and Welfare Mita Hospital

Key exclusion criteria

none

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Tamura

Organization

International University of Health and Welfare, Mita Hospital

Division name

Cardiovascular internal medicine

Zip code

108-8329

Address

1-4-3 Mita, Minato-ku Tokyo

TEL

03-3451-8121

Email

u1@iuhw.ac.jp


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Tamura

Organization

International University of Health and Welfare, Mita Hospital

Division name

Cardiology

Zip code

108-8329

Address

1-4-3 Mita, Minato-ku Tokyo

TEL

03-3451-8121

Homepage URL


Email

u1@iuhw.ac.jp


Sponsor or person

Institute

Ministry of Health, Labor and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

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

International University of Health and Welfare, Mita Hospital

Address

1-4-3 Mita, Minato-ku Tokyo, 108-832

Tel

03-3451-8121

Email

soumu-mita.hosp@iuhw.ac.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

2020 Year 03 Month 07 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

2017 Year 02 Month 27 Day

Date of IRB

2017 Year 02 Month 27 Day

Anticipated trial start date

2017 Year 02 Month 27 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation items
Medical history, family history, symptoms, complications

Sample
5 ml of blood


Management information

Registered date

2020 Year 03 Month 07 Day

Last modified on

2020 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045316


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name