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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003340
Receipt No. 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

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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
Institute Sekino Hospital
Institute
Department

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
URL(English) https://upload.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


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