Prospective Evaluation of Adventitial Histopathology in Borderline Ascending Aortic Dilatatio

NCT07034586 | Active Not Recruiting

• 1 other identifier: SUKAEK-2023 1/19
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

Aortic Dissection Risk Prediction; Borderline Aortic Dilatation; Ascending Aortic Aneurysm; Coronary Artery Bypass Grafting (CABG)

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative period (within 1 month)

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Faculty of Medicine

Samsun, 55090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Aneurysm, Ascending Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Emrah Ereren

  Samsun University Faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

TU (1)