UMIN-CTR Clinical Trial

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
Email	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
Email	norikazu_maeda@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016776