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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033308
Receipt No. R000037971
Official scientific title of the study 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 2018/07/20

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Basic information
Official scientific title of the study Relationship between coronary artery plaque burden and High Mobility Group Box 1 (HMGB1): prospective cohort study
Title of the study (Brief title) 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 instantaneous wave free ratio (iFR) or fractional flow reserve (FFR) in coronary angiography
Key secondary outcomes i) Comparison of HMGB1 and lipid plaque burden detected by integrated backscatter intravascular ultrasound (IB-IVUS)
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 Koichiro Matsumura
Organization Kansai Medical University Medical Center
Division name Department of Cardiology
Address 10-15, Fumizono-cho, Moriguchi-shi, Osaka
TEL 06-6992-1001
Email kmatsumura1980@yahoo.co.jp

Public contact
Name of contact person Koichiro Matsumura
Organization Kansai Medical University Medical Center
Division name Department of Cardiology
Address 10-15, Fumizono-cho, Moriguchi-shi, Osaka
TEL 06-6992-1001
Homepage URL
Email kmatsumura1980@yahoo.co.jp

Sponsor
Institute Kansai Medical University Medical Center
Institute
Department

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

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information none

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037971

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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