臨床研究等提出・公開システム

Date of registration	Sept. 05, 2023
Last modified on	May. 08, 2025
Trial ID	jRCT1050230098

Scientific Title	Exploring Vascular Inflammation Mechanisms Using Transcriptome Analysis of Coronary Plaques
Public Title	Exploring Vascular Inflammation Mechanisms Using Transcriptome Analysis of Coronary Plaques

Contact for Scientific Queries	Name	Fukuda Daiju
	Affiliation	Osaka Metropolitan University Graduate School of Medicine
	Address	1-4-3 Asahi-cho, Abeno-ku, Osaka, Japan
	Telephone	+81-6-6645-3801
	E-mail	daiju.fukuda@omu.ac.jp
Contact for Public Queries	Name	Otsuka Kenichiro
	Affiliation	Osaka Metropolitan University Graduate School of Medicine
	Address	1-4-3 Asahi-cho, Abeno-ku, Osaka, Japan
	Telephone	+81-6-6645-3801
	E-mail	otsukakenichiro1@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		Sept. 05, 2023
Target sample size		64
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	1. scheduled to undergo percutaneous coronary intervention using directional coronary atherectomy (DCA) between the date of jRCT publication and March 2027 at Osaka Metropolitan University Hospital or collaborating institutions 2. diagnosed with coronary artery disease (angina pectoris, asymptomatic myocardial ischemia, unstable angina pectoris, non-ST-elevation myocardial infarction, ST-elevation myocardial infarction) by diagnostic imaging tests (coronary CT, coronary angiography) 3. age 20 years or older at the time of initial consent
	Exclusion Criteria	1. patients with unstable respiratory and circulatory status requiring ventilator or mechanical support 2. patients after cardiopulmonary resuscitation 3. patients who are deemed unsuitable for DCA due to highly calcified coronary arteries 4. other patients deemed unsuitable for DCA by the surgeon
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Coronary artery disease
Health Condition(s) Keyword		atheroscleros, inflammation, single cell analysis, RNA-seq
Primary Outcome(s)		This study will perform a comprehensive analysis of coronary plaque specimens in two groups of patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), to elucidate gene expression and related signals involved in plaque destabilization.
Secondary Outcome(s)		Secondary endpoints: Comparison of intravascular imaging findings and transcriptome analysis by the following categories 1. clinical diagnosis (myocardial infarction and unstable angina) and CCS 2. presence of plaque rupture/erosion and stratified plaque by optical frequency domain imaging (OFDI) 3. presence of low-absorption-area plaques on coronary computed tomography (CT) 4. coronary CT with/without perivascular adipose tissue attenuation

Primary Sponsor	none

Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address	6F Abeno Medix, 1-2-7 Asahi-machi, Abeno-ku, Osaka City, Osaka
Telephone	+81-6-6645-3456
E-Mail	gr-a-knky-crb@omu.ac.jp
Approval Status	Approval
Date of approval	Aug. 30, 2023

Plan to share IPD	Yes

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 08, 2025	(this page)	Changes
1	Sept. 05, 2023	Detail

List of change history