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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006505
Receipt No. 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 2020/05/18

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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
Email 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
Email ayaori@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

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
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 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
2022 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
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007715

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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