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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name