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

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

Study Overview

• Status: Not yet recruiting
• 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
• Intervention / Treatment: Diagnostic test: aneurysmectomy with sampling of a segment of the aneurysm wall

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Andrey A Karpenko, PhD; Phone Number: +79139504100; Email: andreikarpenko@rambler.ru
• Study Contact Backup: Name: Alexandr A Gostev, PhD; Phone Number: +79139555074; Email: a_gostev@meshalkin.ru

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
  • Novosibirsk, Russian Federation
    • E. Meshalkin National Medical Research Center
  • Novosibirskaya Obl
    • Novosibirsk, Novosibirskaya Obl, Russian Federation, 630005
      • Alexander A Gostev

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female patients aged 45 to 75 with a diagnosed aneurysmal dilatation of the abdominal aorta requiring its surgical correction, recruited in accordance with the inclusion/exclusion criteria

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculate the relationship between the strength properties of the tissue and its ultrasonic spectral characteristics	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of elastic-elastic properties of the aortic wall using ultrasonic speckle tracking	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. with the construction of a graph of elastic deformation segment by segment	at least one day prior to surgery
Measurement of the strength properties of the aneurysm wall in uniaxial tension in vitro	evaluate the elastic properties of the tested sample and obtain parameters such as Young's modulus (the slope of the strain-stress diagram in the linear section at small strains)	1 month
Measure linearity limits as well as shear yield strength in vitro	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	1 month

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: speckle tracking; aneurysm wall strength; shear yield strength
• Other Study ID Numbers: NRICP 22/11/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Access to data after first publication at the request of researchers
• IPD Sharing Time Frame: Access to data after first publication at the request of researchers
• IPD Sharing Access Criteria: on personal request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No