Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05634018
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calculate the relationship between the strength properties of the tissue and its ultrasonic spectral characteristics', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Measurement of elastic-elastic properties of the aortic wall using ultrasonic speckle tracking', 'timeFrame': 'at least one day prior to surgery', '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. with the construction of a graph of elastic deformation segment by segment'}, {'measure': 'Measurement of the strength properties of the aneurysm wall in uniaxial tension in vitro', 'timeFrame': '1 month', 'description': "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)"}, {'measure': 'Measure linearity limits as well as shear yield strength in vitro', 'timeFrame': '1 month', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aneurysm wall strength', 'speckle tracking', 'shear yield strength'], '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']}, 'descriptionModule': {'briefSummary': 'Identification of the regression model between the strength properties of tissue and its ultrasonic spectral characteristics.', 'detailedDescription': "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.\n\nIn 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an aneurysmal expansion of the abdominal aorta who are indicated for surgery.\n* Patients who consented to participate in this study\n\nExclusion Criteria:\n\n* Chronic heart failure III-IV functional class according to the NYHA classification;\n* Chronic decompensated "pulmonary" heart;\n* Severe hepatic or renal insufficiency (bilirubin \\> 35 mmol / l, glomerular filtration rate \\< 60 ml / min);\n* Polyvalent drug allergy;\n* Malignant oncological diseases in the terminal stage with a predicted lifespan of up to 6 months;\n* Acute violation of cerebral circulation;'}, 'identificationModule': {'nctId': 'NCT05634018', 'briefTitle': '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', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NRICP 22/11/22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'aneurysmectomy with sampling of a segment of the aneurysm wall', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nIn 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.\n\nThe 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '630005', 'city': 'Novosibirsk', 'state': 'Novosibirskaya Obl', 'country': 'Russia', 'facility': 'Alexander A Gostev', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'E. Meshalkin National Medical Research Center', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Andrey A Karpenko, PhD', 'role': 'CONTACT', 'email': 'andreikarpenko@rambler.ru', 'phone': '+79139504100'}, {'name': 'Alexandr A Gostev, PhD', 'role': 'CONTACT', 'email': 'a_gostev@meshalkin.ru', 'phone': '+79139555074'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Access to data after first publication at the request of researchers', 'ipdSharing': 'YES', 'description': 'Access to data after first publication at the request of researchers', 'accessCriteria': 'on personal request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}