Prospective Evaluation of Adventitial Histopathology in Borderline Ascending Aortic Dilatatio

NCT ID: NCT07034586

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-09-01

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Adults aged between 20 and 70 years

2. Patients scheduled for elective open-heart coronary artery bypass grafting (CABG)

3. Patients undergoing their first cardiac surgery

4. Metabolically stable patients

5. Aortic diameter:

1. Observational aortic dilatation group: between 4.0 cm and 5.0 cm

2. Control group: less than 4.0 cm

6. Written informed consent obtained from the patient

Exclusion Criteria

1. History of previous cardiac surgery

2. History of aortic dissection or rupture

3. Known genetic syndromes (e.g., Marfan, Loeys-Dietz, Ehlers-Danlos)

4. Known systemic vasculitis

5. Presence of acute infection or systemic inflammatory disease

6. Inadequate biopsy material for pathological analysis

7. Patients not undergoing any aortic intervention during surgery

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emrah Ereren

Role: STUDY_CHAIR

Samsun University Faculty of medicine

Locations

Samsun University Faculty of Medicine

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SUKAEK-2023 1/19

Identifier Type: -

Identifier Source: org_study_id