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Recruiting NCT07053254

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

Observational Coronary Artery Occlusive Disease (CAOD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Occlusive Disease (CAOD). Basic parameters: 19 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Identification of gene expression profiles associated with vascular stiffness in graft tissues [Time frame: At the time of surgery (single timepoint sample collection)]
Secondary outcome measures (1)
  • Validation of stiffness-related gene targets and correlation with clinical and histological parameters [Time frame: Within 2 year after tissue collection]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 1 center
  • Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University — Seoul

Identifiers

NCT: NCT07053254 · 4-2022-0197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗