UMIN-CTR Clinical Trial

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 Tetsuo Middle name Last name Shoji
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Vascular Medicine
Zip code	545-8585
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 Tetsuo Middle name Last name Shoji
Organization	Osaka City University Graduate School of Medicine
Division name	Osaka City University Graduate School of Medicine
Zip code	545-8585
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	Ethical Committee of Osaka City University Graduate School of Medicine
Address	1-2-7-601, Asahi-machi, Abeno-ku, Osaka, Japan
Tel	06-6645-3456
Email	ethics@med.osaka-cu.ac.jp

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）、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）、神戸大学　循環器内科学（兵庫県）、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）、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）、国立循環器病研究センター研究所　病態代謝部（大阪府）

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	Completed
Date of protocol fixation	2017 Year 08 Month 31 Day
Date of IRB	2017 Year 10 Month 04 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry	2020 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information	Observational study

Management information
Registered date	2017 Year 12 Month 29 Day
Last modified on	2021 Year 12 Month 03 Day

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