Ascending Aortic AneurysmNCT07034586
Prospective Evaluation of Adventitial Histopathology in Borderline Ascending Aortic Dilatatio
An observational study of Ascending Aortic Aneurysm and Aortic Adventitial Pathology, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study investigates microscopic changes in the outer layer (adventitia) of the ascending aorta in patients undergoing coronary artery bypass grafting (CABG) surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Ascending Aortic Aneurysm, Aortic Adventitial Pathology, Coronary Artery Bypass Grafting (CABG)
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Sep 2025
- How long will I take part?
- 1 Month
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients aged 20 to 70 years undergoing elective coronary artery bypass grafting (CABG) surgery at a tertiary cardiovascular surgery center. Participants are divided into two groups based on preoperative ascending aortic diameter measured by imaging: Study Group: Patients with borderline ascending aortic dilatation (diameter between 4.0 cm and 5.0 cm) Control Group: Patients with normal ascending aortic diameter (<4.0 cm) All participants are undergoing their first cardiac surgery, are metabolically stable, and do not have a known history of aortic dissection, connective tissue disease, or systemic vasculitis.
Who may be able to join
- Adults aged between 20 and 70 years
- Patients scheduled for elective open-heart coronary artery bypass grafting (CABG)
- Patients undergoing their first cardiac surgery
- Metabolically stable patients
- Aortic diameter:
- Observational aortic dilatation group: between 4.0 cm and 5.0 cm
- Control group: less than 4.0 cm
- Written informed consent obtained from the patient
Who cannot join
- History of previous cardiac surgery
- History of aortic dissection or rupture
- Known genetic syndromes (e.g., Marfan, Loeys-Dietz, Ehlers-Danlos)
- Known systemic vasculitis
- Presence of acute infection or systemic inflammatory disease
- Inadequate biopsy material for pathological analysis
- Patients not undergoing any aortic intervention during surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University Faculty of Medicine
Samsun, 55090
About this study
Official title: A Prospective Analysis of Adventitial Pathology in Patients Undergoing Coronary Bypass With Borderline Ascending Aortic Dilatation
This prospective study investigates microscopic changes in the outer layer (adventitia) of the ascending aorta in patients undergoing coronary artery bypass grafting (CABG) surgery. The study includes two groups of patients: (1) those with borderline ascending aortic dilatation (4.0-5.0 cm), and (2) a control group with normal aortic diameter (<4.0 cm), all undergoing the same surgical procedure. During CABG, a small circular punch is routinely made in the ascending aorta for the proximal saphenous vein graft anastomosis. The tissue removed from this punch site is collected and used for histopathological and immunohistochemical analysis. The study aims to determine whether adventitial changes correlate with aortic size and whether these changes can help identify patients at risk for future aortic dissection or rupture. The findings may guide surgical decision-making in patients with borderline aortic enlargement.
- Conditions
- Ascending Aortic Aneurysm, Aortic Adventitial Pathology, Coronary Artery Bypass Grafting (CABG), Borderline Aortic Dilatation
- Keywords
- Aortic Dissection Risk Prediction, Borderline Aortic Dilatation, Ascending Aortic Aneurysm, Coronary Artery Bypass Grafting (CABG)
- Medical subject headings
- Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Aort Dilated Group | Patients undergoing elective coronary artery bypass grafting (CABG) with an ascending aortic diameter between 4.0 cm and 5.0 cm. These patients do not have known genetic aortopathy and are undergoing their first cardiac surgery. Aortic tissue samples are collected during surgery from the punch biopsy site used for proximal anastomosis. | |
| Observational Control Group | Patients undergoing elective CABG with an ascending aortic diameter less than 4.0 cm. These patients also do not have known aortopathies and are undergoing their first cardiac surgery. Punch biopsy material is similarly collected for histopathological evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Histopathological Findings and Aortic Diameter
Comparison of adventitial tissue samples between patients with borderline ascending aortic dilatation (4.0-5.0 cm) and those with normal-sized aortas (<4.0 cm). Pathological evaluation includes staining for Carbonic Anhydrase IX (CA9), Smooth Muscle Actin (SMA), D2-40, Verhoeff-Van Gieson elastin, and Prussian blue. The presence of fibrosis, inflammation, neovascularization, and hypoxia-related markers will be recorded. Analysis of the correlation between the degree of histopathological changes and the measured ascending aortic diameter. Metrics include inflammatory cell infiltration, vasa vasorum density, and adventitial fibrosis severity.
Measured: Postoperative period (within 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emrah Ereren, Study chair, Samsun University Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034586
- Sponsor's protocol ID
- SUKAEK-2023 1/19
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Adventitial Pathology in Patients Undergoing Coronary Bypass With Borderline Ascending Aortic Dilatation
- ClinicalTrials.gov ID
- NCT07034586
- Acronym / sponsor ID
- SUKAEK-2023 1/19
- Conditions
- Ascending Aortic Aneurysm, Aortic Adventitial Pathology, Coronary Artery Bypass Grafting (CABG), Borderline Aortic Dilatation
- Keywords
- Aortic Dissection Risk Prediction, Borderline Aortic Dilatation, Ascending Aortic Aneurysm, Coronary Artery Bypass Grafting (CABG)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Jun 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 prospective study investigates microscopic changes in the outer layer (adventitia) of the ascending aorta in patients undergoing coronary artery bypass grafting (CABG) surgery. The study includes two groups of patients: (1) those with borderline ascending aortic dilatation (4.0-5.0 cm), and (2) a control group with normal aortic diameter (<4.0 cm), all undergoing the same surgical procedure. During CABG, a small circular punch is routinely made in the ascending aorta for the proximal saphenous vein graft anastomosis. The tissue removed from this punch site is collected and used for histopathological and immunohistochemical analysis. The study aims to determine whether adventitial changes correlate with aortic size and whether these changes can help identify patients at risk for future aortic dissection or rupture. The findings may guide surgical decision-making in patients with borderline aortic enlargement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Aort Dilated Group | – | –Patients undergoing elective coronary artery bypass grafting (CABG) with an ascending aortic diameter between 4.0 cm and 5.0 cm. These patients do not have known genetic aortopathy and are undergoing their first cardiac surgery. Aortic tissue samples are collected during surgery from the punch biopsy site used for proximal anastomosis. |
| Observational Control Group | – | –Patients undergoing elective CABG with an ascending aortic diameter less than 4.0 cm. These patients also do not have known aortopathies and are undergoing their first cardiac surgery. Punch biopsy material is similarly collected for histopathological evaluation. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients aged 20 to 70 years undergoing elective coronary artery bypass grafting (CABG) surgery at a tertiary cardiovascular surgery center. Participants are divided into two groups based on preoperative ascending aortic diameter measured by imaging: Study Group: Patients with borderline ascending aortic dilatation (diameter between 4.0 cm and 5.0 cm) Control Group: Patients with normal ascending aortic diameter (<4.0 cm) All participants are undergoing their first cardiac surgery, are metabolically stable, and do not have a known history of aortic dissection, connective tissue disease, or systemic vasculitis.
Key inclusion criteria (8 listed)
- Adults aged between 20 and 70 years
- Patients scheduled for elective open-heart coronary artery bypass grafting (CABG)
- Patients undergoing their first cardiac surgery
- Metabolically stable patients
- Aortic diameter:
Key exclusion criteria (7 listed)
- History of previous cardiac surgery
- History of aortic dissection or rupture
- Known genetic syndromes (e.g., Marfan, Loeys-Dietz, Ehlers-Danlos)
- Known systemic vasculitis
- Presence of acute infection or systemic inflammatory disease
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
Association Between Histopathological Findings and Aortic Diameter
Time frame: Postoperative period (within 1 month)
Comparison of adventitial tissue samples between patients with borderline ascending aortic dilatation (4.0-5.0 cm) and those with normal-sized aortas (<4.0 cm). Pathological evaluation includes staining for Carbonic Anhydrase IX (CA9), Smooth Muscle Actin (SMA), D2-40, Verhoeff-Van Gieson elastin, and Prussian blue. The presence of fibrosis, inflammation, neovascularization, and hypoxia-related markers will be recorded. Analysis of the correlation between the degree of histopathological changes and the measured ascending aortic diameter. Metrics include inflammatory cell infiltration, vasa vasorum density, and adventitial fibrosis severity.
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 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Emrah Ereren study chair
Samsun University Faculty of medicine
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 Ascending Aortic Aneurysm and Aortic Adventitial Pathology, run by Samsun University at 1 site in Turkey (Türkiye).
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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Histopathological Findings and Aortic Diameter (time frame: Postoperative period (within 1 month)). 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 24 Jun 2025.