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临床试验/NCT05634018
NCT05634018尚未招募不适用

Prospective Assessment of the Biomechanical Properties of the Wall of an Aneurysmal-altered Abdominal Aorta According to the Results of in Vivo Ultrasound and an Associated Study of Strength Characteristics in Vitro

Meshalkin Research Institute of Pathology of Circulation3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
3
主要终点
Calculate the relationship between the strength properties of the tissue and its ultrasonic spectral characteristics

研究概览

简要总结

Identification of the regression model between the strength properties of tissue and its ultrasonic spectral characteristics.

详细描述

Patients with identified aneurysms of the abdominal aorta, who are planned for surgical treatment, undergo an ultrasound examination of the abdominal aorta to assess the elastic properties of the aortic wall using ultrasound speckle tracking. Intraoperatively, the accessible wall of the abdominal aortic aneurysm with a size of at least 10 cm2 is taken. and a section of the thrombotic cup of the aorta with a volume of up to 5 cm3. Pathologically altered tissues extracted for research are subject to removal during a standard operation for prosthetics of the infrarenal aorta and have no clinical significance for the patient.

In in vitro studies, the strength properties of the aneurysm wall are measured under uniaxial tension on a tensile testing machine, which makes it possible to evaluate the elastic properties of the test sample and obtain such parameters as Young's modulus (slope of the strain-stress diagram in a linear section at small deformations), as well as limiting strain values and loading.

The evaluation of the linearity boundaries of the surface under study, as well as the yield strength of the vascular wall and thrombotic masses, is evaluated under shear stresses using a rheometer. The tests will be carried out using special ground plane-to-plane instruments. To correlate the mechanical properties with the structural composition of the aneurysm tissue, spectral analysis of the tested tissues using the laser-induced fluorescence method and histological examination by staining the obtained sections for elastic fibers, fibrous tissues and calcification will be used.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with an aneurysmal expansion of the abdominal aorta who are indicated for surgery.
  • •Patients who consented to participate in this study

排除标准

  • •Chronic heart failure III-IV functional class according to the NYHA classification;
  • •Chronic decompensated "pulmonary" heart;
  • •Severe hepatic or renal insufficiency (bilirubin > 35 mmol / l, glomerular filtration rate < 60 ml / min);
  • •Polyvalent drug allergy;
  • •Malignant oncological diseases in the terminal stage with a predicted lifespan of up to 6 months;
  • •Acute violation of cerebral circulation;

结局指标

主要结局

Calculate the relationship between the strength properties of the tissue and its ultrasonic spectral characteristics

时间窗: 1 year

Identification of the regression relationship between the elasto-elastic and strength properties of the tissue and its ultrasonic characteristics will make it possible to determine the most significant diagnostic ultrasonic criteria for aortic wall deformation, which determine the increased risk of its rupture and thromboembolic complications in a particular patient.

次要结局

  • Measure linearity limits as well as shear yield strength in vitro(1 month)
  • Measurement of elastic-elastic properties of the aortic wall using ultrasonic speckle tracking(at least one day prior to surgery)
  • Measurement of the strength properties of the aneurysm wall in uniaxial tension in vitro(1 month)

研究者

发起方
Meshalkin Research Institute of Pathology of Circulation
申办方类型
Network
责任方
Sponsor

研究点 (3)

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