UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	relation between xanthine oxidoreductase and coronary plaque or endotherial function
Title of the study (Brief title)	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	Yoshio Kobayashi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Email	yoshio.kobayashi@wonder.ocn.ne.jp

Public contact
Name of contact person	Yuichi Saito
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Homepage URL
Email	policemaccho@yahoo.co.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031908