UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014419 |
|---|---|
| Receipt number | R000016776 |
| Scientific Title | Study for Correlation between adiponectin, coronary atherosclerosis, and volume of epicardial fat detected by cardiac CT |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/01/14 18:55:57 |
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Basic information
Public title
Study for Correlation between adiponectin, coronary atherosclerosis, and volume of epicardial fat detected by cardiac CT
Acronym
CACAO Study
Scientific Title
Study for Correlation between adiponectin, coronary atherosclerosis, and volume of epicardial fat detected by cardiac CT
Scientific Title:Acronym
CACAO Study
Region
| Japan |
Condition
Condition
Coronary Artery Diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between coronary artery diseases, fat distribution, and circulating biomarkers
Basic objectives2
Others
Basic objectives -Others
To clarify the correlation between cardiac fat distribution, coronary atherosclerosis, and circulating biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significant correlation between coronary artery diseases, fat distribution, and circulating biomarkers
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who were performed coronary CT and agreed with study protocol.
Key exclusion criteria
(1) Subjects who can not understand study protocol.
(2) Subjects who were implanted with coronary artery stent, were treated by cardiac surgery, were implanted with artificial pacemaker, underwent hemodialysis, and were administered with pioglitazone.
(3) Subjects who were judged inadequate for the study by the attending physician.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iichiro Shimomura |
Organization
Graduate School of Medicine, Osaka
University
Division name
Department of Metabolic Medicine
Zip code
Address
2-2-B5, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3737
ichi@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Maeda |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine
Zip code
Address
2-2-B5, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3737
Homepage URL
norikazu_maeda@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2020 | 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
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
Measurement of adipocytokines, oxidative stresses, and factors relating to atherosclerosis.
Management information
Registered date
| 2014 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016776
