臨床研究等提出・公開システム

Scientific Title	Performance Evaluation of cardioREPO in stress myocardial perfusion scintigraphy for patients with ischemic heart disease
Public Title	cardioREPO study

Contact for Scientific Queries	Name	Miyauchi Hideyuki
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba, JAPAN
	Telephone	+81-43-222-7171
	E-mail	hmiyauchi@chiba-u.jp
Contact for Public Queries	Name	Miyauchi Hideyuki
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba, JAPAN
	Telephone	+81-43-222-7171
	E-mail	hmiyauchi@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 16, 2018
Actual date of first enrollment		Feb. 14, 2019
Target sample size		180
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients undergoing stress myocardial perfusion SPECT 2) Patients agreeing with this study after informed consent
	Exclusion Criteria	1) Patients who are contraindication to stress myocardial perfusion SPECT 2) Patients judged not eligible in this study
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ishcemic heart disease
Intervention(s)		Using personal medical data of patients
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To evaluate the diagnostic accuracy of cardioREPO in coronary artery branch area (left anterior descending, left circumflex, right coronary artery), using image analysis of the myocardial perfusion scintigraphy for patients with ischemic heart disease.
Secondary Outcome(s)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	PDRadiopharma Inc. (The name of the company at the time of funding was FUJIFILM RI Pharma Co., Ltd.)
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana chou-ku Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Mar. 04, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)	UMIN000022294
Issuing Authority	UMIN

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history