Exploring Vascular Inflammation Mechanisms Using Transcriptome Analysis of Coronary Plaques

JRCT ID: jRCT1050230098

Registered date:05/09/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Coronary artery disease
• Date of first enrollment: 05/09/2023
• Target sample size: 64
• Study type: Observational

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fukuda Daiju