UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027855 |
|---|---|
| Receipt number | R000031908 |
| Scientific Title | relation between xanthine oxidoreductase and coronary plaque or endotherial function |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2017/06/21 20:16:21 |
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Basic information
Public title
relation between xanthine oxidoreductase and coronary plaque or endotherial function
Acronym
relation between xanthine oxidoreductase and coronary plaque or endotherial function
Scientific Title
relation between xanthine oxidoreductase and coronary plaque or endotherial function
Scientific Title:Acronym
relation between xanthine oxidoreductase and coronary plaque or endotherial function
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating between xanthine oxidoreductase reactivity and coronary plaque or endothelial function
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation between xanthine oxidoreductase reactivity and coronary lipid plaque with NIRS-IVUS
Key secondary outcomes
1. Relation between xanthine oxidoreductase reactivity and endothelial function with Endo-PAT
2. Distribution of xanthine oxidoreductase reactivity in coronary artery disease
3. Relation between xanthine oxidoreductase reactivity and uric acid
4. Relation between xanthine oxidoreductase reactivity and coronary plaque volume
5. Relation between purine bodies (hypoxanthine, xanthine) and coronary lipid plaque
6. Relation between purine bodies (hypoxanthine, xanthine) and endothelial function
7. Relation between uric acid and coronary plaque or endothelial function
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
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
1. blood test
2. intravascular ultrasonography
3. endothelial function test
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
patient who will undergo percutaneous coronary intervention with NIRS-IVUS in our hospital
Key exclusion criteria
1. patients undergoing hemodialysis
2. patients taking inhibitor of xanthine oxidoreductase
3. patients who are not eligible by the investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
yoshio.kobayashi@wonder.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Saito |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
policemaccho@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2017 | Year | 06 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | 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
| 2017 | Year | 06 | Month | 21 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031908
