UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025649
Receipt No. 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 2017/01/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Soichiro Usui
Organization Kanazawa University Hospital
Division name Cardiovascular Medicine
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL +81-76-265-2238
Email usuiso@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichiro Usui
Organization Kanazawa University Hospital
Division name Cardiovascular Medicine
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL +81-76-265-2238
Homepage URL
Email usuiso@m-kanazawa.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
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 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
Anticipated trial start date
2016 Year 09 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 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
2017 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.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


Contact us.