UMIN-CTR Clinical Trial

Basic information
Public title	The investigation of the relationship between the morphology of coronary atherosclerosis and gene information in coronary artery disease patients.
Acronym	The investigation of gene information in CAD patients.
Scientific Title	The investigation of the relationship between the morphology of coronary atherosclerosis and gene information in coronary artery disease patients.
Scientific Title:Acronym	The investigation of the relationship between the morphology of coronary atherosclerosis and gene information in coronary artery disease patients.
Region	Japan

Condition
Condition	Coronary artery disease patients
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the involvement of somatic mutation in blood and coronary culprit plaques in coronary artery disease patients.
Basic objectives2	Others
Basic objectives -Others	To clarify the relationship between the somatic mutation and the morphology of coronary culprit plaques revealed by single cell RNA and ATAC seq
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The existence of somatic mutation in blood and coronary culprit plaques
Key secondary outcomes	1, The ratio of somatic mutation and the place in gene map of somatic mutation. 2, CT or MRI evaluation of coronary plaques 3, Histological evaluation 4, Single cell RNA and ATAC sequencing of blood and coronary culprit plaque samples 5, The interaction of somatic mutations and single cell RN and ATAC sequencing of blood and coronary culprit plaque samples. 6, Metabolomics in plasma

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 of 20 year of age or over 2, Patients who are candidates for DCA 3, Patients for whom written consent has been obtained by the individual
Key exclusion criteria	Patients taking steroids or undergoing treatment for cancer, or suffering from hepatitis B and C viruses Other patients who are deemed inappropriate by the physician in charge of the study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomoya Middle name Last name Yamashita
Organization	Kobe University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5846
Email	tomoya@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Tomoya Middle name Last name Yamashita
Organization	Kobe University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5846
Homepage URL
Email	tomoya@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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 School of Medicine
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, 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	2022 Year 05 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No other related information

Management information
Registered date	2022 Year 03 Month 09 Day
Last modified on	2022 Year 03 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053755