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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021624
Receipt No. R000024938
Scientific Title Circadian Variation of Serum Uric Acid in Patients with Coronary Artery Diseases
Date of disclosure of the study information 2016/04/01
Last modified on 2018/09/27

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Basic information
Public title Circadian Variation of Serum Uric Acid in Patients with Coronary Artery Diseases
Acronym Circadian Variation of Serum Uric Acid in Patients with Coronary Artery Diseases
Scientific Title Circadian Variation of Serum Uric Acid in Patients with Coronary Artery Diseases
Scientific Title:Acronym Circadian Variation of Serum Uric Acid in Patients with Coronary Artery Diseases
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify circadian variation of serum uric acid and xanthine oxidoreductase(XOR) in patients with coronary artery disease.
Basic objectives2 Others
Basic objectives -Others To assess a relationship between oxidative stress and serum uric acid and XOR.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The endpoint is circadian variation of serum uric acid and XOR, and oxidative stress marker
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 blood and urine examination
study duration: 4 days
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
Key inclusion criteria Patients who are scheduled to undergo percutaneous coronary intervention
Key exclusion criteria ・hyperuricemia or gout under treatment
・under treatmet that affects serum uric acid
・under treatment for sleep apnea syndrome
・chronic obstructive pulmonary disease
・malignancy
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Kasai
Organization Juntendo University School of Medicine, Juntendo Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email tkasai@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Naito
Organization Juntendo University School of Medicine, Juntendo Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email rnaitou@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine, Juntendo Hospital
Institute
Department

Funding Source
Organization SANWA KAGAKU KENKYUSHO CO, LTD
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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

Management information
Registered date
2016 Year 03 Month 26 Day
Last modified on
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024938

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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