跳至主要内容
临床试验/NCT07034586
NCT07034586进行中(未招募)不适用

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

Samsun University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
102
试验地点
1
主要终点
Association Between Histopathological Findings and Aortic Diameter

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Association Between Histopathological Findings and Aortic Diameter

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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