UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002281 |
|---|---|
| Receipt number | 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 21:18:22 |
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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
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
skaichi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002792
