UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022423 |
|---|---|
| Receipt number | R000025790 |
| Scientific Title | Relation between Sleep-disordered Breathing and Renal Dysfunction in Patients with Acute Coronary Syndrome |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2016/05/29 14:53:55 |
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Basic information
Public title
Relation between Sleep-disordered Breathing and Renal Dysfunction in Patients with Acute Coronary Syndrome
Acronym
Relation between Sleep-disordered Breathing and Renal Dysfunction in Patients with Acute Coronary Syndrome
Scientific Title
Relation between Sleep-disordered Breathing and Renal Dysfunction in Patients with Acute Coronary Syndrome
Scientific Title:Acronym
Relation between Sleep-disordered Breathing and Renal Dysfunction in Patients with Acute Coronary Syndrome
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the hypothesis that sleep disordered breathing causes the renal dysfunction observed during hospitalization in ACS patients treated with PCI.
Basic objectives2
Others
Basic objectives -Others
assessment of complication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical association between severe sleep disordered breathing and renal dysfunction at discharge
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients admitted with acute coronary syndrome and performed coronary angiography within 24 hours after their admission.
Key exclusion criteria
died within seven days after admission, chronic kidney disease requiring chronic peritoneal or hemodialysis, chronic heart failure with New York Heart Association Functional Classification>2
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kiyokuni |
Organization
Yokohama City University School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2635
masakiyo@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kiyokuni |
Organization
Yokohama City University School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2635
Homepage URL
masakiyo@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohama Southern 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
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
| 2016 | Year | 05 | Month | 24 | 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
| 2011 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
This is prospective observational study. Between May 2011 and March 2014, we recruit consecutive patients with ACS who are admitted to our institute and underwent coronary angiography within 24 hours after admission. Sleep study will be performed for patients estimated glomeular filtration rate on admission and at discharge will be calculated. We examine relationship between sleep disordered breathing and renay dysfunction using these data.
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2016 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025790
