UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022921 |
|---|---|
| Receipt number | R000026413 |
| Scientific Title | Impact of blood fatty acid on endothelial function in patients with ischemic heart disease |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/06/28 09:27:43 |
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Basic information
Public title
Impact of blood fatty acid on endothelial function in patients with ischemic heart disease
Acronym
Impact of blood fatty acid on endothelial function in patients with ischemic heart disease
Scientific Title
Impact of blood fatty acid on endothelial function in patients with ischemic heart disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
miyoshit@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital, Department of Cardiovascular Medicine
Institute
Department
Personal name
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)
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
| 2016 | Year | 08 | 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
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026413
