The Characteristics and Treatment Mechanism of Vascular Grafts in Elderly Patients With CAOD Through Single-cell Transcriptome Analysis

Recruiting

• Conditions: Coronary Artery Occlusive Disease (CAOD)

• Registration Number: NCT07053254
• Lead Sponsor: Yonsei University

Brief Summary

This study aims to establish a cardiovascular biobank using vascular grafts obtained from participants with coronary artery occlusive disease (CAOD). Through genomic and transcriptomic analyses, the study seeks to characterize the biological features of the vascular grafts and identify potential therapeutic targets and mechanisms related to vascular remodeling and stiffness.

Detailed Description

This observational study will utilize discarded vascular graft tissues obtained during coronary artery bypass grafting (CABG) procedures in participants with coronary artery occlusive disease (CAOD). Our surgical team performs over 200 CABG operations annually, allowing for the consistent and ethical acquisition of excess graft tissue without requiring any additional procedures or interventions for participants.

Collected tissues will be processed as follows:

A portion of each graft will be preserved in RNAlater solution for molecular analyses, including total RNA sequencing, quantitative PCR, and western blotting.

Another portion will be fixed in formalin and embedded for histological examination, including immunohistochemistry (IHC), to validate mechanisms of vascular remodeling and stiffness at the protein level.

This approach ensures that all biological samples are collected with minimal risk and no additional burden to participants, while enabling comprehensive multi-omic analysis to investigate the pathophysiological characteristics of vascular grafts in elderly CAOD patients.

Study Timeline

• Study Start: 2022-04-12
• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Primary Completion: 2027-04-11
• Study Completion: 2027-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults aged 19 years or older, Patients scheduled to undergo coronary artery bypass grafting (CABG), Patients who voluntarily provide written informed consent for study participation, Patients who are able and willing to comply with study procedures during the study period

Exclusion Criteria

• Pediatric or adolescent patients under 18 years of age, Patients requiring concomitant surgical correction for valvular heart disease, Patients undergoing reoperative (redo) cardiac surgery, Patients who decline to provide informed consent prior to surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of gene expression profiles associated with vascular stiffness in graft tissues	At the time of surgery (single timepoint sample collection)	To identify differentially expressed genes and signaling pathways related to vascular stiffness using total RNA sequencing of vascular graft tissues obtained during coronary artery bypass grafting (CABG).

Secondary Outcome Measures

Name	Time	Method
Validation of stiffness-related gene targets and correlation with clinical and histological parameters	Within 2 year after tissue collection	To validate selected stiffness-associated gene targets identified through RNA sequencing using qPCR and western blotting; to assess corresponding protein expression through immunohistochemistry; and to correlate transcriptomic findings with participants' clinical characteristics such as age, hypertension, and diabetes.

Trial Locations

Locations (1)

Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of