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临床试验/NCT05650892
NCT05650892已完成不适用

Male-female Differences in Immunohistological and Biomechanical Properties of the Thoracic Aorta

Hanneke Takkenberg2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Male-female differences in immunohistochemical and mass spectrometry-based estrogen and testosterone receptor expression levels (and density) in the proximal aortic wall

研究概览

简要总结

Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men (1). The mechanisms for these male-female difference in TAA outcome remain, however, unclear. The timing of preventive surgery is now not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be needed.

详细描述

Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men(1). However, the mechanisms for these male-female differences in TAA outcome remain unclear. The timing of preventive surgery is not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be beneficial for outcome.

The current research project aims to implement male-female specific insights into aortic root and ascending aorta characteristics into clinical practice, allowing better identification of high risk Thoracic Aortic Aneurysm (TAA) patients and better timing of intervention. With this study the investigators aim to obtain insight into male-female differences in the immunohistological and biomechanical properties of the thoracic aortic wall. In order to reveal possible mechanisms for male-female differences in TAA.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥ 18 years old) who have a thoracic aortic aneurysm and are scheduled for elective thoracic aortic surgery in the Erasmus MC or the LUMC.

排除标准

  • Patients with a known connective tissue disease (e.g. Marfan Syndrome and Ehlers-Danlos syndromes).
  • Connective tissue disease,

研究组 & 干预措施

Sample collection aortic tissue

Sample collection thoracic aorta tissue

结局指标

主要结局

Male-female differences in immunohistochemical and mass spectrometry-based estrogen and testosterone receptor expression levels (and density) in the proximal aortic wall

时间窗: 1 year

To investigate male-female differences in estrogen receptor (ESR-alpha and ESRbeta) and testosterone receptor (AR) tissue expression in the wall of the aortic root and ascending aorta by immunohistochemical techniques and mass spectometry. Comparisons will be made using a students t-test.

次要结局

  • Male-female differences in immunohistochemical or mass spectrometry-based sex hormone receptor expression levels (and density) in the proximal aortic wall.(1 year)

研究者

发起方
Hanneke Takkenberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hanneke Takkenberg

Principal investigator

Erasmus Medical Center

研究点 (2)

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