UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relation between Sleep-disordered Breathing and Renal Dysfunction in Patients with Acute Coronary Syndrome
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masayoshi Kiyokuni
Organization	Yokohama City University School of Medicine
Division name	Department of Medical Science and Cardiorenal Medicine
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2635
Email	masakiyo@yokohama-cu.ac.jp

Public contact
Name of contact person	Masayoshi Kiyokuni
Organization	Yokohama City University School of Medicine
Division name	Department of Medical Science and Cardiorenal Medicine
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2635
Homepage URL
Email	masakiyo@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025790