UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047309 |
|---|---|
| Receipt number | R000053792 |
| Scientific Title | A registry study on primary/idiopathic triglyceride deposit cardiomyovasculopathy |
| Date of disclosure of the study information | 2022/03/30 |
| Last modified on | 2024/12/26 20:34:19 |
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Basic information
Public title
A registry study on primary/idiopathic triglyceride deposit cardiomyovasculopathy
Acronym
A registry study on primary/idiopathic triglyceride deposit cardiomyovasculopathy
Scientific Title
A registry study on primary/idiopathic triglyceride deposit cardiomyovasculopathy
Scientific Title:Acronym
A registry study on primary/idiopathic triglyceride deposit cardiomyovasculopathy
Region
| Japan |
Condition
Condition
primary/idiopathic triglyceride deposit cardiomyovasculopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to construct a registry; in order to understand the onset status of triglyceride deposit cardiomyovasculopathy (TGCV) in Japan with patients' background and natural history of the disease, and to explore disease-specific prognostic factors.
Basic objectives2
Others
Basic objectives -Others
Natural history
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The period between the date of TGCV diagnosis and the date of death due to any cause
Key secondary outcomes
-Clinical and laboratory profile of patients with idiopathic TGCV
-Changes in each laboratory findings
-Presence (date of occurrence or treatment) or absence of various events
-Exploration for prognostic factors
-Changes in laboratory findings and frequency of events before and after nutritional therapy using tricaprin-containig foods, etc.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients (excluding under 20 years old) who have been confirmed as TGCV based on the diagnostic criteria for TGCV by a cardiologist.
Key exclusion criteria
The patients who refused to participate in the study by opt-out
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Hirano |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Triglyceride Science
Zip code
565-0874
Address
6-2-4 Furuedai, Suita, Osaka, Japan Quantitative Biology BuildingB, RIKEN
TEL
06-6872-8215
registry@cnt-osaka.com
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Hirano |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Triglyceride Science
Zip code
565-0874
Address
6-2-4 Furuedai, Suita, Osaka, Japan Quantitative Biology BuildingB, RIKEN
TEL
06-6872-8215
Homepage URL
registry@cnt-osaka.com
Sponsor or person
Institute
The Japan TGCV Registry Study steering committee
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Osaka University Clinical Research Review Committee
Address
2-15 Yamadaoka, Suita, Osaka
Tel
06-6879-5111
rinri@hp-crc.med.osaka-u.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
大阪大学医学部附属病院（大阪府）
愛知医科大学（愛知県）
兵庫医科大学病院（兵庫県）
千葉大学医学部附属病院（千葉県）
九州大学病院（福岡県）
名古屋大学医学部附属病院（愛知県）
順天堂大学大学院医学研究科（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 30 | 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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since this is a cohort study (observational study), it does not specify the examination and treatment policy, and also does not specify the schedule of observation and examination during the follow-up period. Therefore, the observation and assessment will be conducted according to the standard schedule conducted as on-the-job medical care, the data will be collected retrospectively. Safety information such as adverse events caused by treatment will not be collected.
Management information
Registered date
| 2022 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053792
