Clinical trial NCT05634018: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2022-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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;

Primary outcomes:
measure: Calculate the relationship between the strength properties of the tissue and its ultrasonic spectral characteristics
timeFrame: 1 year
Secondary outcomes:
measure: Measurement of elastic-elastic properties of the aortic wall using ultrasonic speckle tracking
timeFrame: at least one day prior to surgery
measure: Measurement of the strength properties of the aneurysm wall in uniaxial tension in vitro
timeFrame: 1 month
measure: Measure linearity limits as well as shear yield strength in vitro
timeFrame: 1 month
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Alexander A Gostev
state: Novosibirskaya Obl
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
city: Novosibirsk
country: Russian Federation
facility: E. Meshalkin National Medical Research Center
Study officials:
References: