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NCT Number: NCT07034586

Prospective Evaluation of Adventitial Histopathology in Borderline Ascending Aortic Dilatatio

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University Faculty of Medicine

Samsun, 55090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

A Prospective Analysis of Adventitial Pathology in Patients Undergoing Coronary Bypass With Borderline Ascending Aortic Dilatation

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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