UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Significance of Fatty Acid in Patients With Peripheral Artery Disease: Single Center Prospective Observational Study
Title of the study (Brief title)	SARDINE
Region	Japan

Condition
Condition	Peripheral Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider the value of serum fatty acid in patients with peripheral artery disease, and reveal the significance of it
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The value of serum fatty acid in patients with peripheral artery disease
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	16 years-old <=
Age-upper limit	101 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who visited the ambulatory of our Hospital with the complaint of chest or lower limbs symptoms for the first time, and who had Endvascular Treatment since 27 October 2015
Key exclusion criteria	The patients with the history of taking ethylicosapentate or with unknown medical history
Target sample size	1000

Research contact person
Name of lead principal investigator	Yoshimitsu Soga
Organization	Kokura Memorial Hospital
Division name	Cardiology
Address	3-5-7 Asano Kita-ku Kokura Kitakyusyu-shi Fukuoka-ken Japan
TEL	093-511-2000
Email	soga@circulation.jp

Public contact
Name of contact person	Miho Shinnmura
Organization	Kokura Memorial Hospital
Division name	Cardiology
Address	3-5-7 Asano Kita-ku Kokura Kitakyusyu-shi Fukuoka-ken Japan
TEL	093-511-2000
Homepage URL
Email	kmhptca@kokura-heart.com

Sponsor
Institute	Kokura Memorial Hospital
Institute
Department

Funding Source
Organization	Kokura Memorial Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 27 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	1271 patients were enrolled in this study between 27 October 2015 and 29 March 2017, and it has already finised

Management information
Registered date	2017 Year 05 Month 17 Day
Last modified on	2017 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031215