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UnknownNCT05634018

Comparison 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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Meshalkin Research Institute of Pathology of Circulation · Network
Sex
All
Age
45 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTaneurysmectomy with sampling of a segment of the aneurysm wallPatients with aneurysms of the abdominal aorta undergo an ultrasound examination of the abdominal aorta to assess the elastic properties of the aortic wall. The accessible wall of the abdominal aortic aneurysm is taken intraoperatively. In in vitro studies, the strength properties of the aneurysm wall are measured during uniaxial tension on a tensile testing machine, which makes it possible to evaluate the elastic properties of the test sample. The assessment of the boundaries of the linearity 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. To correlate the mechanical properties with the structural composition of the aneurysm tissue, spectral analysis of the studied tissues by laser-induced fluorescence and histological examination with staining of the obtained sections for the presence of elastic fibers, fibrous tissues and calcification will be used.

Timeline

Start date
2023-01-01
Primary completion
2023-01-30
Completion
2023-04-30
First posted
2022-12-01
Last updated
2022-12-14

Locations

3 sites across 1 country: Russia

Source: ClinicalTrials.gov record NCT05634018. Inclusion in this directory is not an endorsement.

Comparison of the Biomechanical Properties of the Wall of an Aneurysmal-altered Abdominal Aorta According to the Results (NCT05634018) · Clinical Trials Directory