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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002281
Receipt No. R000002792
Scientific Title Evaluation study of biological markers involved in cardiovascular diseases in childhood
Date of disclosure of the study information 2009/08/15
Last modified on 2009/08/01

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Basic information
Public title Evaluation study of biological markers involved in cardiovascular diseases in childhood
Acronym Evaluation study of biological markers involved in cardiovascular diseases in childhood
Scientific Title Evaluation study of biological markers involved in cardiovascular diseases in childhood
Scientific Title:Acronym Evaluation study of biological markers involved in cardiovascular diseases in childhood
Region
Japan

Condition
Condition cardiovascular diseases
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether biological markers, which were reportedly involved in the mechanisms of cardiovascular diseases in adulthood, were also in those in childhood and to use the data for drug target discovery in a following study.
Basic objectives2 Others
Basic objectives -Others To examine whether biological markers, which were reportedly involved in the mechanisms of cardiovascular diseases in adulthood, were also in those in childhood and to use the data for drug target discovery in a following study.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We examine the values of biological markers from blood samples of patients with cardiovascular diseases in both acute and recovery phases. We also compare these values with those of normal control.
Key secondary outcomes none

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
0 years-old <=
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria patients with cardiovascular disease whose onset are in childhood
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiraku Doi
Organization Kyoto university
Division name Pediatrics
Zip code
Address Kawahara-machi 54, Syogoin, Kyoto
TEL 075-751-3298
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Kaichi
Organization Kyoto university
Division name Pediatrics
Zip code
Address Kawahara-machi 54, Syogoin, Kyoto
TEL 075-751-3298
Homepage URL
Email skaichi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

Funding Source
Organization Kyoto University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
2009 Year 08 Month 15 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2015 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective cohort

Management information
Registered date
2009 Year 08 Month 01 Day
Last modified on
2009 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002792

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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