UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of blood fatty acid on endothelial function in patients with ischemic heart disease
Title of the study (Brief title)	Impact of blood fatty acid on endothelial function in patients with ischemic heart disease
Region	Japan

Condition
Condition	Patients with ischemic heart disease
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of eicosapentaenoic acid on endothelial function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in Flow Mediated Dilation after 3 months treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	eicosapentaenoic acid 1800mg/day
Interventions/Control_2	no treatment
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	Patients with stable ischemic heart disease and LDL-C<100 mg/dL, and without treatment of eicosapentaenoic acid, who is under cardiac rehabilitation program
Key exclusion criteria	1)no treatment of statin 2)treatment of eicosapentaenoic acid 3)Pregnant 4)allergic to study drug 5)severe liver disease 6)bleeding tendency or bleeding 7)not appropriate for this study by judgement of a physician
Target sample size	30

Research contact person
Name of lead principal investigator	Toru Miyoshi
Organization	Okayama University Hospital
Division name	Department of Cardiovascular Medicine
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Email	miyoshit@cc.okayama-u.ac.jp

Public contact
Name of contact person	Toru Miyoshi
Organization	Okayama University Hospital
Division name	Department of Cardiovascular Medicine
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Homepage URL
Email	miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital, Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Okayama University Hospital, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 28 Day
Anticipated trial start date	2016 Year 09 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

Management information
Registered date	2016 Year 06 Month 27 Day
Last modified on	2018 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026413