臨床研究等提出・公開システム

Date of registration	Oct. 26, 2022
Last modified on	Oct. 26, 2022
Trial ID	jRCT1040220081

Scientific Title	Association of epicardial fat with cardiac structure and function and cardiovascular outcomes: a protocol for systematic review and meta-analysis (Epicardial fat and cardiovascular diseases)
Public Title	Epicardial fat and cardiovascular diseases: meta-analysis (Epicardial fat and cardiovascular diseases)

Contact for Scientific Queries	Name	Fukuta Hidekatsu
	Affiliation	Nagoya City University Graduate School of Medical Sciences
	Address	1 Kawasumi Mizuho-cho Mizuho-ku
	Telephone	+81-52-853-8221
	E-mail	fukuta-h@med.nagoya-cu.ac.jp
Contact for Public Queries	Name	Fukuta Hidekatsu
	Affiliation	Nagoya City University Graduate School of Medical Sciences
	Address	1 Kawasumi Mizuho-cho Mizuho-ku
	Telephone	+81-52-853-8221
	E-mail	fukuta-h@med.nagoya-cu.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Oct. 26, 2022
Target sample size		4210
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	(1) quantified epicardial fat volume using CT or MRI; (2) measured cardiac structure and function on echocardiography or assessed cardiovascular outcomes; and (3) described the relation of epicardial fat volume with cardiac structure and function or cardiovascular outcomes.
	Exclusion Criteria	Case-control studies
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Patients with cardiovascular diseases and general population
Primary Outcome(s)		A composite of cardiovascular death and hospitalization for heart failure
Secondary Outcome(s)		Cardiovascular events including cardiovascular death and hospitalization for heart failure and cardiac structure and function.

Primary Sponsor	Hidekatsu Fukuta

Secondary Sponsor

Source of Monetary Support	JSPS KAKENHI, Grants-in-aid for Scientific Research
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nagoya City University Institutional Review Board
Address	1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya, Aichi
Telephone	+81-52-851-5511
E-Mail	irb_jimu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	Sept. 27, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none