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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
