Coronary Artery Occlusive Disease (CAOD)NCT07053254
The Characteristics and Treatment Mechanism of Vascular Grafts in Elderly Patients With CAOD Through Single-cell Transcriptome Analysis
An observational study of Coronary Artery Occlusive Disease (CAOD), run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Coronary Artery Occlusive Disease (CAOD)
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Apr 2022to 11 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will include adult patients diagnosed with coronary artery occlusive disease (CAOD) who are undergoing elective or urgent coronary artery bypass grafting (CABG). Vascular graft tissues (e.g., internal mammary artery or saphenous vein) that are not required for anastomosis and would otherwise be discarded during surgery will be collected for molecular and histological analysis. No additional procedures or interventions will be performed on participants beyond standard clinical care.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, 120-752
Young Nam Youn, MD, 82-02-2228-8480, ynyoun@yuhs.ac
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Occlusive Disease (CAOD)
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of gene expression profiles associated with vascular stiffness in graft tissues
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).
Measured: At the time of surgery (single timepoint sample collection)
Secondary outcomes (1)
Validation of stiffness-related gene targets and correlation with clinical and histological parameters
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.
Measured: Within 2 year after tissue collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start12 Apr 2022
- Primary completion11 Apr 2027 (estimated)
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Occlusive Disease (CAOD)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053254
- Sponsor's protocol ID
- 4-2022-0197
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics and Treatment Mechanism of Vascular Grafts in Elderly Patients With CAOD Through Single-cell Transcriptome Analysis
- ClinicalTrials.gov ID
- NCT07053254
- Acronym / sponsor ID
- 4-2022-0197
- Conditions
- Coronary Artery Occlusive Disease (CAOD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 11 Apr 2027 (estimated)
- Study completion
- 11 Apr 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include adult patients diagnosed with coronary artery occlusive disease (CAOD) who are undergoing elective or urgent coronary artery bypass grafting (CABG). Vascular graft tissues (e.g., internal mammary artery or saphenous vein) that are not required for anastomosis and would otherwise be discarded during surgery will be collected for molecular and histological analysis. No additional procedures or interventions will be performed on participants beyond standard clinical care.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of gene expression profiles associated with vascular stiffness in graft tissues
Time frame: 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).
1 secondary outcome
Validation of stiffness-related gene targets and correlation with clinical and histological parameters
Time frame: Within 2 year after tissue collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Occlusive Disease (CAOD), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of gene expression profiles associated with vascular stiffness in graft tissues (time frame: At the time of surgery (single timepoint sample collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.