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
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
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
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
