UMIN-CTR Clinical Trial

Basic information
Public title	The investigation of the relationship between coronary atherosclerosis and clinical data
Acronym	Coronary artery plaque analysis
Scientific Title	The investigation of the relationship between coronary atherosclerosis and clinical data
Scientific Title:Acronym	Analysis of coronary atherosclerosis by single cell RNA sequencing
Region	Japan

Condition
Condition	Coronary atherosclerosis
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the difference of characterization between stable and unstable coronary atherosclerosis by single-cell RNA sequencing
Basic objectives2	Others
Basic objectives -Others	Elucidation of the mechanism of the development of arterial sclerosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cluster analysis of single-cell RNA sequencing and cluster analysis of gene expression variation in each cluster on both stable and unstable coronary atherosclerosis
Key secondary outcomes	Relationship between plaque assessment collected by DCA and various plaque data 1.Plaque evaluation by CT 2.Plaque assessment by cMRI 3. Bulk RNA sequencing 4. microRNA sequencing 5. Histological evaluation

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	(1) Patients 20 years of age or older at the time of percutaneous coronary intervention(PCI) (2) Patients who underwent PCI with directional coronary atherectomy and had a plaque collected (3) Patients for whom written consent has been obtained by the individual
Key exclusion criteria	(1) Patients taking steroids, autoimmune diseases, undergoing treatment for cancer, or suffering from hepatitis B and C viruses (2) Other patients who are deemed inappropriate by the physician in charge of the study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tomoya Middle name Last name Yamashita
Organization	Kobe University Hospital
Division name	The division of Cardiovascular medicine
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Kobe, Japan
TEL	078-382-5111
Email	tomoya@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Yamamoto
Organization	Hyogo Brain and Heart Centor
Division name	The division of Cardiovascular medicine
Zip code	6700981
Address	Kou-Saisyo520, Himeji, Hyogo, Japan
TEL	079-293-3131
Homepage URL
Email	y0493589m@hotmail.co.jp

Sponsor
Institute	Hyogo Brain and Heart Centor Kobe University Hospital
Institute
Department

Funding Source
Organization	Kobe University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital
Address	7-5-2, Kusunoki-cho, Kobe, Japan
Tel	078-382-5111
Email	chiken@med.kobe-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

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 15 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	Open public recruiting
Date of protocol fixation	2020 Year 05 Month 31 Day
Date of IRB	2020 Year 10 Month 22 Day
Anticipated trial start date	2020 Year 10 Month 22 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2020 Year 06 Month 13 Day
Last modified on	2020 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046521