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

NCT ID: NCT05634018

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-04-30

Brief 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

the Strength Properties of the Aorta in Vivo; the Strength Properties of the Aorta in Vitro; Regression Model of Aortic Strength Properties in Vitro and in Vitro

Keywords

aneurysm wall strength; speckle tracking; shear yield strength

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

aneurysmectomy with sampling of a segment of the aneurysm wall

Patients 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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;

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alexander A Gostev

Novosibirsk, Novosibirskaya Obl, Russia

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology

Novosibirsk, , Russia

E. Meshalkin National Medical Research Center

Novosibirsk, , Russia

Countries

Russia

Central Contacts

Andrey A Karpenko, PhD

Role: CONTACT

Phone: +79139504100

Email: andreikarpenko@rambler.ru

Alexandr A Gostev, PhD

Role: CONTACT

Phone: +79139555074

Email: a_gostev@meshalkin.ru

Other Identifiers

NRICP 22/11/22

Identifier Type: -

Identifier Source: org_study_id