the Strength Properties of the Aorta in VivoNCT05634018
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
An observational study of the Strength Properties of the Aorta in Vivo and the Strength Properties of the Aorta in Vitro, run by Meshalkin Research Institute of Pathology of Circulation at 3 sites in Russia.
Trial summary
Identification of the regression model between the strength properties of tissue and its ultrasonic spectral characteristics. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- 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
- What is being tested?
- aneurysmectomy with sampling of a segment of the aneurysm wall
- How many people
- 50 participants
- Where
- 3 sitesRussia
- Study dates
- 1 Jan 2023to 30 Apr 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with an aneurysmal expansion of the abdominal aorta who are indicated for surgery.
- Patients who consented to participate in this study
Who cannot join
- 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;
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Alexander A Gostev
Novosibirsk, Novosibirskaya Obl, 630005
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Novosibirsk, 630055
E. Meshalkin National Medical Research Center
Novosibirsk
About this study
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
Identification of the regression model between the strength properties of tissue and its ultrasonic spectral characteristics.
Read the 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
- Being tested
- aneurysmectomy with sampling of a segment of the aneurysm wall
- Keywords
- aneurysm wall strength, speckle tracking, shear yield strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aneurysmectomy with sampling of a segment of the aneurysm wallDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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
Measured: 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)
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Strength Properties of the Aorta in VivoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634018
- Sponsor's protocol ID
- NRICP 22/11/22
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to data after first publication at the request of researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05634018
- Acronym / sponsor ID
- NRICP 22/11/22
- 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 type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with an aneurysmal expansion of the abdominal aorta who are indicated for surgery.
- Patients who consented to participate in this study
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aneurysmectomy 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. | Diagnostic test | – |
Primary outcome
Calculate the relationship between the strength properties of the tissue and its ultrasonic spectral characteristics
Time frame: 1 year
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.
3 secondary outcomes
Measurement of elastic-elastic properties of the aortic wall using ultrasonic speckle tracking
Time frame: at least one day prior to surgery
Measurement of the strength properties of the aneurysm wall in uniaxial tension in vitro
Time frame: 1 month
Measure linearity limits as well as shear yield strength in vitro
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Yes. Access to data after first publication at the request of researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Strength Properties of the Aorta in Vivo and the Strength Properties of the Aorta in Vitro, run by Meshalkin Research Institute of Pathology of Circulation at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrey A Karpenko, PhD (+79139504100, andreikarpenko@rambler.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate the relationship between the strength properties of the tissue and its ultrasonic spectral characteristics (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.