UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevalance of the sleep apnea syndrome in cardiac surgery patients
Title of the study (Brief title)	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	Akira Sezai
Organization	Nihon University school of medicine
Division name	Department of Cardiovascular Surgery
Address	30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	asezai.med@gmail.com

Public contact
Name of contact person	Akira Sezai
Organization	Nihon University school of medicine
Division name	Department of Cardiovascular Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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