UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010603 |
|---|---|
| Receipt number | 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 13:19:30 |
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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
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
tanishigem@yahoo.co.jp
Sponsor or person
Institute
Surugadai Nihon University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012394
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
