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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010603
Receipt No. R000012394
Scientific Title Effects of serum fatty acids on cardiovascular risk in patients with cardiovascular disease
Date of disclosure of the study information 2013/05/01
Last modified on 2015/10/27

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Basic information
Public title Effects of serum fatty acids on cardiovascular risk in patients with cardiovascular disease
Acronym The serum fatty acids and cardiovascular risk
Scientific Title Effects of serum fatty acids on cardiovascular risk in patients with cardiovascular disease
Scientific Title:Acronym The serum fatty acids and cardiovascular risk
Region
Japan

Condition
Condition Patients with the presence of one or more risk factors for CAD
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was designed as a hospital-based cross-sectional study to investigate the relationships between the serum EPA/AA ratio and a prevalence of CAD, and to assess the association of the serum fatty acids with the serum levels of atherosclerotic-related markers in patients with the presence of one or more risk factors for CAD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the relationships between the serum fattyacids and a prevalence of CAD
Key secondary outcomes To assess the association of the serum fatty acids with the serum levels of atherosclerotic-related markers

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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with the presence of one or more risk factors for CAD.
Key exclusion criteria The exclusion criteria included inability to obtain consent, current treatment with n-3PUFAs, and acute coronary syndrome (ACS) within 3 months preceding.
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigemasa Tani
Organization Surugadai Nihon University Hospital
Division name Department of Cardiology
Zip code
Address 1-8-13 Kandasurugada, Chiyodaku, 101-8309, Tokyo
TEL 03-3293-1711
Email tanishigem@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigemasa Tani
Organization Surugadai Nihon University Hospital
Division name Department of Cardiology
Zip code
Address 1-8-13 kandasurugadai, Chiyodaku, Tokyo 8309, Japan
TEL 03-3293-1711
Homepage URL
Email tanishigem@yahoo.co.jp

Sponsor
Institute Surugadai Nihon University Hospital
Institute
Department

Funding Source
Organization This work was supported by KAKENHI Grant Number 23590757 of the Japan Society for the Promotion of Science (JSPS).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 20 Day
Last follow-up date
2013 Year 08 Month 30 Day
Date of closure to data entry
2013 Year 08 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information This study was designed as a hospital-based cross-sectional study to investigate the relationships between the serum fatty acids and a prevalence of CAD, and to assess the association of the serum fatty acids with the serum levels of atherosclerotic-related markers in patients with the presence of one or more risk factors for CAD

Management information
Registered date
2013 Year 04 Month 27 Day
Last modified on
2015 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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