UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007715