UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018198 |
|---|---|
| Receipt number | R000021071 |
| Scientific Title | Analysis of Metabolic Remodeling in Cardiovascular Diseases by Metabolomics |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2015/07/08 19:00:35 |
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Basic information
Public title
Analysis of Metabolic Remodeling in Cardiovascular Diseases by Metabolomics
Acronym
Analysis of Metabolic Remodeling in Cardiovascular Diseases by Metabolomics
Scientific Title
Analysis of Metabolic Remodeling in Cardiovascular Diseases by Metabolomics
Scientific Title:Acronym
Analysis of Metabolic Remodeling in Cardiovascular Diseases by Metabolomics
Region
| Japan |
Condition
Condition
Cardiovascular Diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate unknown metabolic mechanism participating the onset and progress of cardiovascular diseases by metabolomics.
Basic objectives2
Others
Basic objectives -Others
Observational study
To elucidate unknown metabolic mechanism participating the onset and progress of cardiovascular diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Metabolite, Cardiovascular remodeling, Cardiovascular events
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cardiovascular diseases or suspected who need cardiovascular catheterization.
Key exclusion criteria
except the above-mentioned patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Mianmino |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Cardiovascular Biology and Medicine
Zip code
Address
1-757 Asahimachidori, Chuo-ku, Niigata 951-8510
TEL
025-227-2185
tminamino@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Komei Tanaka |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Cardiovascular Biology and Medicine
Zip code
Address
1-757 Asahimachidori, Chuo-ku, Niigata 951-8510
TEL
025-227-2185
Homepage URL
komei.tanaka@cf7.so-net.ne.jp
Sponsor or person
Institute
Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute for Advanced Biosciences, Keio University
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
新潟大学大学院医歯学総合研究科（新潟県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | 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
| 2015 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2015 | Year | 07 | Month | 05 | Day |
Last modified on
| 2015 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021071
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
