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

NCT05634018 | Unknown

• 1 other identifier: NRICP 22/11/22
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Measure linearity limits as well as shear yield strength in vitro

  1 month

Interventions

aneurysmectomy with sampling of a segment of the aneurysm wall DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (3)

Alexander A Gostev

Novosibirsk, Novosibirskaya Obl, 630005, Russia

Location

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

Novosibirsk, 630055, Russia

Location

E. Meshalkin National Medical Research Center

Novosibirsk, Russia

Location

Central Study Contacts

Andrey A Karpenko, PhD

CONTACT

+79139504100; andreikarpenko@rambler.ru

Alexandr A Gostev, PhD

CONTACT

+79139555074; a_gostev@meshalkin.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: January 1, 2023
• Primary Completion: January 30, 2023
• Study Completion: April 30, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Access to data after first publication at the request of researchers
• Access Criteria: on personal request

Locations

RU (3)