UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030635 |
|---|---|
| Receipt number | 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 | 2021/12/03 13:41:05 |
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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 | 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
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
t-shoji@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034945
