UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025649
Receipt number R000029508
Scientific Title Evaluating the role of a liver-derived secretory protein, hepatokines, in atherosclerosis
Date of disclosure of the study information 2017/01/20
Last modified on 2023/02/03 07:47:02

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Basic information

Public title

Evaluating the role of a liver-derived secretory protein, hepatokines, in atherosclerosis

Acronym

The role of hepatokines in atherosclerosis

Scientific Title

Evaluating the role of a liver-derived secretory protein, hepatokines, in atherosclerosis

Scientific Title:Acronym

The role of hepatokines in atherosclerosis

Region

Japan


Condition

Condition

atherosclerosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the expression of hepatokines,including selenoprotein P in atherosclerosis

Basic objectives2

Others

Basic objectives -Others

Relation between concentration of hepatokines and severity of atherosclerosis

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

concentration of hepatokines

Key secondary outcomes

clinical characteristics, such as severity of atherosclerosis, profile of peripheral monocyte, cardiac or carotid artery echo and blood data.


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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have a plant to receive coronary angiography

Key exclusion criteria

Criteria for exclusion included cardiac mechanical support, biventricular pacemaker placement,
hemodynamically significant uncorrected ventricular arrhythmia, serum creatinine level greater than 2.0 mg/dL, hemofiltration or dialysis, hypersensitivity for iodine, heparin or antiplatelet agent, malignant disease, comorbid conditions with an expected survival of less than 12 months, and active infection disease

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Soichiro
Middle name
Last name Usui

Organization

Kanazawa University Hospital

Division name

Cardiovascular Medicine

Zip code

9208641

Address

13-1 Takara-machi, Kanazawa, Ishikawa

TEL

+81-76-265-2238

Email

usuiso@staff.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name Soichiro
Middle name
Last name Usui

Organization

Kanazawa University Hospital

Division name

Cardiovascular Medicine

Zip code

9208641

Address

13-1 Takara-machi, Kanazawa, Ishikawa

TEL

+81-76-265-2238

Homepage URL


Email

usuiso@staff.kanazawa-u.ac.jp


Sponsor or person

Institute

Kanazawa University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of System Biology, Kanazawa University Graduate School of Advanced Preventive Medical Sciences

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

Medical Ethics Committee of Kanazawa University

Address

13-1 Takaramachi Kanazawa, Ishikawa, Japan

Tel

076-265-2000

Email

rinri@adm.kanazawa-u.ac.jp


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

金沢大学附属病院(石川県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 20 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

Enrolling by invitation

Date of protocol fixation

2016 Year 05 Month 18 Day

Date of IRB

2016 Year 05 Month 18 Day

Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Examination of hepatokines concentration in patients who have a plan to receive coronary angiography and obtain informed consent for using samples.
Investigation of the association between selenoprotein P and clinical characteristics, such as severity of atherosclerosis, profile of peripheral monocyte, cardiac or carotid artery echo and blood data.


Management information

Registered date

2017 Year 01 Month 12 Day

Last modified on

2023 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029508


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name