UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006505 |
|---|---|
| Receipt number | R000007715 |
| Scientific Title | Study of lipid profile and gene analyses in patients with cardiovascular diseases and lifestyle-related diseases |
| Date of disclosure of the study information | 2011/10/07 |
| Last modified on | 2022/10/20 17:24:49 |
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Basic information
Public title
Study of lipid profile and gene analyses in patients with cardiovascular diseases and lifestyle-related diseases
Acronym
lipid profile and gene analyses in patients with cardiovascular diseases and lifestyle-related diseases
Scientific Title
Study of lipid profile and gene analyses in patients with cardiovascular diseases and lifestyle-related diseases
Scientific Title:Acronym
lipid profile and gene analyses in patients with cardiovascular diseases and lifestyle-related diseases
Region
| Japan |
Condition
Condition
Cardiovascular diseases/Cerebrovascular diseases/lifestyle-related diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Neurology | Geriatrics |
| Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore novel risk factors for cardiovascular diseases and lifestyle- related diseases by analyzing lipid profile and gene polymorphisms.
Basic objectives2
Others
Basic objectives -Others
To explore novel risk factors for diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipid profile including cholesterol efflux etc.Gene analysis(SNPs,deletion,
insertion,CNV,expression etc)
Key secondary outcomes
Blood and urine analyses including Hemoglobin A1c levels, Urinary acid,
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria)
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
1)Patients with cardiovascular diseases, cerebrovascular diseases and lifestyle-related diseases, and their relatives who are willing to accept the analyses of lipid profile and gene
2)Patients who gave written informed consent
Key exclusion criteria
1)Subjects with known bleeding tendency
2)Subjects with anemia
3)Subjects whose doctor in charge do not agree to join the trial
Target sample size
2300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Ikewaki |
Organization
National Defense Medical College
Division name
Department of Internal Medicine1
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1597
katsunorike@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ayaori |
Organization
National Defense Medical College
Division name
Department of Internal Medicine1
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1597
Homepage URL
ayaori@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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
防衛医科大学校
埼玉県立循環器・呼吸器病センター
所沢ハートセンター
ひろせクリニック
豊岡第一病院
圏央所沢病院
所沢中央病院
所沢第一病院
東京慈恵会医科大学
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze lipid profile including cholesterol efflux etc and Gene(SNPs,deletion,insertion,CNV,expression etc) in Cardiovascular disease/Cerebrovascular disease/lifestyle-related disease.
Management information
Registered date
| 2011 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007715
