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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name