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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030635
Receipt No. R000034945
Scientific Title Cholesterol Absorption and Cholesterol synthesis in High-risk patiEnts (CACHE study)
Date of disclosure of the study information 2018/01/01
Last modified on 2017/12/29

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Basic information
Public title Cholesterol Absorption and Cholesterol synthesis in High-risk patiEnts (CACHE study)
Acronym Cholesterol Absorption and Cholesterol synthesis in High-risk patiEnts (CACHE study)
Scientific Title Cholesterol Absorption and Cholesterol synthesis in High-risk patiEnts (CACHE study)
Scientific Title:Acronym Cholesterol Absorption and Cholesterol synthesis in High-risk patiEnts (CACHE study)
Region
Japan

Condition
Condition 1. Cardiovascular disease (coronary arterial disease, cerebrovascular disease, peripheral arterial disease)
2. Conditions at high risk of cardiovascular disease (diabetes mellitus, chronic kidney disease including stage 5D)
3. Those who do not have the above diseases
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To examine the possible relationship between the markers of cholesterol metabolism and cardiovascular disease.
2. To examine possible alterations in the levels of cholesterol metabolism markers in diabetes mellitus, chronic kidney disease, familial hypercholesterolemia.
3. To examine possible effects of medications on the levels of cholesterol metabolism markers.
Basic objectives2 Others
Basic objectives -Others Associations of biomarkers with medical conditions and diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiovascular disease (Coronary arterial disease, cerebrovascular disease, peripheral arterial disease)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients at high-risk of cardiovascular disease (coronary arterial disease, cerebrovascular disease, peripheral arterial disease, diabetes mellitus, chronic kidney disease including those treated with dialysis, familial hypercholesterolemia), or individuals who were examined for the screening of these conditions.
2. Individuals whose cholesterol metabolism markers were already measured (serum lathosterol, campesterol, and citosterol levels)
Key exclusion criteria 1. Participants will be opt-out when the participants and/or their family members do not want to participate in this study upon information disclosure of this study.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Shoji
Organization Osaka City University Graduate School of Medicine
Division name Department of Vascular Medicine
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, JAPAN
TEL 06-6645-3930
Email t-shoji@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuo Shoji
Organization Osaka City University Graduate School of Medicine
Division name Osaka City University Graduate School of Medicine
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, JAPAN
TEL 06-6645-3930
Homepage URL
Email t-shoji@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 大阪市立大学 血管病態制御学(大阪府)、大阪大学・りんくう総合医療センター(大阪府)、岩手医科大学 糖尿病・代謝内科(岩手県)、東京慈恵医科大学附属 柏病院(東京都)、国際医療福祉大学 看護学科(千葉県)、九州大学病院 循環器内科(福岡県)、島根大学 総合医療講座(島根県)、鹿児島大学 糖尿病・内分泌内科学(鹿児島県)、神戸大学 循環器内科学(兵庫県)、横浜市立大学医療センター 循環器内科(神奈川県)、広島大学 循環器内科学(広島県)、熊本大学 糖尿病・代謝・内分泌内科(熊本県)、岐阜大学 循環病態学(岐阜県)、東京女子医科大学 循環器内科(東京都)、東京女子医科大学 糖尿病センター(東京都)、宮崎大学医学部 神経呼吸内分泌代謝学分野(宮崎県)、自治医科大学 地域医療学センター(栃木県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2017 Year 12 Month 29 Day
Last modified on
2017 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034945

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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