UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033308 |
|---|---|
| Receipt number | R000037971 |
| Scientific Title | Relationship between coronary artery plaque burden and High Mobility Group Box 1 (HMGB1): prospective cohort study |
| Date of disclosure of the study information | 2018/07/07 |
| Last modified on | 2021/01/05 09:30:21 |
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Basic information
Public title
Relationship between coronary artery plaque burden and High Mobility Group Box 1 (HMGB1): prospective cohort study
Acronym
Coronary artery plaque and HMGB1
Scientific Title
Relationship between coronary artery plaque burden and High Mobility Group Box 1 (HMGB1): prospective cohort study
Scientific Title:Acronym
Coronary artery plaque and HMGB1
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the relationship between coronary artery plaque burden and serum level of high mobility group box 1 (HMGB1) as a inflammatory biomarker
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of HMGB1 and lipid plaque burden detected by integrated backscatter intravascular ultrasound (IB-IVUS)
Key secondary outcomes
i) Comparison of HMGB1 and instantaneous wave free ratio (iFR) or fractional flow reserve (FFR) in coronary angiography
ii) Comparison of HMGB1 and % coronary stenosis calculated by quantitative coronary angiography (QCA)
iii) Comparison of HMGB1 and slow flow phenomenon during coronary intervention
iv) Comparison of HMGB1 and the grade of coronary collateral vessel
v) Comparison of HMGB1 and the incidence of restenosis after coronary intervention
vi) Comparison of HMGB1 and the incidence of composite endpoint of cardiac death, myocardial infarction, revascularization and stent thrombosis
vii) Comparison of HMGB1 and inflammatory biomarkers of histone H3, syndical-1, lipoprotein(a) and oxidized lipoprotein(a), in addition relationship between these biomarkers and iFR, IB-IVUS and cardiovascular events
viii) Comparison of HMGB1 and ankle brachial index (ABI)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Underwent elective coronary angiography or coronary intervention
Key exclusion criteria
patients with fever-up, acute and chronic infection, thyroid abnormality, collagen disease, using oral steroid therapy or using inhaled corticosteroid. a patient judged inappropriate by doctor
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
5708507
Address
10-15, Fumizono-cho, Moriguchi-shi, Osaka
TEL
06-6992-1001
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
5708507
Address
10-15, Fumizono-cho, Moriguchi-shi, Osaka
TEL
06-6992-1001
Homepage URL
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Shine-Test Corporation
IRB Contact (For public release)
Organization
Kansai Medical University Medical Center
Address
10-15, Fumizono-cho, Moriguchi-shi, Osaka
Tel
0669921001
bandoshi@takii.kmu.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 07 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037971
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
