UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019318 |
|---|---|
| Receipt number | R000022336 |
| Scientific Title | Effect of eicosapentaenoic acid administration on apnea hypopnea index in sleep apnea patients who underwent percutaneous coronary intervention |
| Date of disclosure of the study information | 2015/10/12 |
| Last modified on | 2019/04/14 09:52:01 |
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Basic information
Public title
Effect of eicosapentaenoic acid administration on apnea hypopnea index in sleep apnea patients who underwent percutaneous coronary intervention
Acronym
Effect of eicosapentaenoic acid administration on sleep apnea patients
Scientific Title
Effect of eicosapentaenoic acid administration on apnea hypopnea index in sleep apnea patients who underwent percutaneous coronary intervention
Scientific Title:Acronym
Effect of eicosapentaenoic acid administration on sleep apnea patients
Region
| Japan |
Condition
Condition
Sleep apnea
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of eicosapentaenoic acid administration on apnea hypopnea index in sleep apnea patients who underwent percutaneous coronary intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apnea hypopnea index (comparison between before and 6 months after administration)
Key secondary outcomes
(i) Fatty acid fraction, lipid profiles
(ii) Intima-media thickness of carotid artery
(iii) Cardiac functions on transthoracic echocardiography
(iv) Flow-mediated dilation (FMD)
(v) Neurohumoral factors (plasma renin activity, plasma aldosterone concentration, catecholamines, brain natriuretic peptide (BNP))
(vi) Systemic blood pressure, heart rate
(vii) Cardiothoracic ratio
(viii) Adverse cardiovascular event rate
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
Oral eicosapentaenoic acid 1800 mg/day (900 mg x2)
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
Sleep apnea patients who are diagnosed by apnea hypopnea index>5 on polysomnography after percutaneous coronary intervention, and also already diagnosed with dyslipidemia, with informed consent for inclusion.
Key exclusion criteria
(i) Patients who are already administered eicosapentaenoic acid at the time of polysomnography
(ii) Patients with allergic reaction against eicosapentaenoic acid
(iii) Patients with malignant neoplasm with life expectancy <6 months
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Jujo |
Organization
Nishiarai Heart Center Hospital
Division name
Department of Cardiology
Zip code
123-0845
Address
1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL
+81358380730
juken1123@mac.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Jujo |
Organization
Nishiarai Heart Center Hospital
Division name
Department of Cardiology
Zip code
123-0845
Address
1-12-8 Nishiarai-honcho, Adachi-ku, Tokyo, Japan
TEL
+81358380730
Homepage URL
juken1123@mac.com
Sponsor or person
Institute
Nishiarai Heart Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Nishiarai Heart Center Hospital
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
Seiwakai Medical Ethics Committee
Address
5-7-14, Nishiarai-honcho, Adachi-ku, Tokyo, Japan
Tel
+81338407111
office-3@nishiarai.or.jp
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
西新井ハートセンター病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 12 | 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
100
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022336
