UMIN-CTR Clinical Trial

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
Email	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
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

IRB Contact (For public release)
Organization	Kansai Medical University Medical Center
Address	10-15, Fumizono-cho, Moriguchi-shi, Osaka
Tel	0669921001
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037971