UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003340
Receipt number R000004050
Scientific Title Prevalance of the sleep apnea syndrome in cardiac surgery patients
Date of disclosure of the study information 2010/03/16
Last modified on 2018/03/26 11:15:23

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Basic information

Public title

Prevalance of the sleep apnea syndrome in cardiac surgery patients

Acronym

Prevalance of the sleep apnea syndrome in cardiac surgery patients

Scientific Title

Prevalance of the sleep apnea syndrome in cardiac surgery patients

Scientific Title:Acronym

Prevalance of the sleep apnea syndrome in cardiac surgery patients

Region

Japan


Condition

Condition

Cardiac surgery patients

Classification by specialty

Pneumology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the prevalance of sleep apnea syndrome in cardiac surgery patients, and compare from various data with the severity.

Basic objectives2

Others

Basic objectives -Others

prevalance

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The prevalance of sleep apnea syndrome in cardiac surgery patients.

Key secondary outcomes

1)risk factor (Ht, DM, HL, etc)
2)left ventricular function by echocardiography
3)ANP, BNP
4)renin activity, angiotensin-II, aldsterone
5)high sensitivity CRP, oxidative LDL


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing cardiac surgery
Patients from whom informed consent was obtained

Key exclusion criteria

Doctor's decision not to register to this regimen

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University school of medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

asezai.med@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University school of medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL


Email

asezai.med@gmail.com


Sponsor or person

Institute

Sekino Hospital

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

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

2010 Year 03 Month 16 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

2008 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2008 Year 02 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

I)prevalence of sleep apnea syndrome

II-1)risk factor (Ht, DM, HL, etc)
II-2)left ventricular function by echocardiography
II-3)ANP, BNP
II-4)renin activity, angiotensin-II, aldsterone
II-5)high sensitivity CRP, oxidative LD


Management information

Registered date

2010 Year 03 Month 16 Day

Last modified on

2018 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004050


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name