UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accumulation of epicardial adipose tissue is associated with cardiovascular disease: Histopathological study
Title of the study (Brief title)	EAT and CAD histopathology
Region	Japan

Condition
Condition	coronary artery disease and valvular heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucide whether epicardial adipose accumulation is associated with coronary atherosclerosis and ventricular hypertropy by histopathological approarch in patients undergoing open heart surgery
Basic objectives2	Others
Basic objectives -Others	pathological evaluation
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	expression of adipocytokines
Key secondary outcomes	none

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	30 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Coronary artery disease or valvular heart disease patients undergoing CABG and/or valvular surgery 2) age>=30 years old. 3) all patients had undergone cardiac catheter examination, echocardiography, and cardiac CT angiography before the surgery
Key exclusion criteria	Critical heart failure, shock status, nonconciousness
Target sample size	50

Research contact person
Name of lead principal investigator	Hideya Yamamoto
Organization	Hiroshima University, Graduate School of Biomedical and Health Sciences
Division name	Cardiovascular Medicine
Address	1-2-3 Kasumi Minamiku Hiroshima City
TEL	082-257-5540
Email	hideyayama@hiroshima-u.ac.jp

Public contact
Name of contact person	Hideya Yamamoto
Organization	Hiroshima University, Graduate School of Biomedical and Health Sciences
Division name	Cardiovascular Medicine
Address	1-2-3 Kasumi Minamiku Hiroshima City
TEL	082-257-5540
Homepage URL	http://home.hiroshima-u.ac.jp/cardio
Email	hideyayama@hiroshima-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Hiroshima University, Graduate School of Biomedical and Health Sciences
Institute
Department

Funding Source
Organization	Hiroshima University, Graduate School of Biomedical and Health Sciences
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 06 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We expect that significant differences are observed with regard to expression of adiponectin and other inflammatory cytokines compared between with and without coronar artery disease.

Management information
Registered date	2013 Year 05 Month 07 Day
Last modified on	2016 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012461