Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 4:47 AM
Study NCT ID:
NCT07453251
Status:
RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000094628', 'term': 'Aortic Root Aneurysm'}, {'id': 'D000082882', 'term': 'Bicuspid Aortic Valve Disease'}, {'id': 'D001019', 'term': 'Aortic Rupture'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D017542', 'term': 'Aneurysm, Ruptured'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Resected aneurysmal aortic segment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Standardize mechanical measurements', 'timeFrame': 'During laboratory testing', 'description': 'Assess from a methodological point of view the various aspects and results of the different test and identify the ideal testing method (uniaxial vs biaxial)'}], 'primaryOutcomes': [{'measure': 'Strength to rupture', 'timeFrame': 'During laboratory testing', 'description': 'Define the strength to rupture of the removed aortic segments and its relation with the circumferential and longitudinal direction along the aortic axis.'}], 'secondaryOutcomes': [{'measure': 'Evaluate aortic characteristics', 'timeFrame': 'From surgery to laboratory testing', 'description': 'Evaluate multiple characteristics of the surgically excised pathologically enlarged aortic segments: shape alteration, tensile strength, elasticity capacity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortic aneurysm', 'bicuspid aortic valve', 'tricuspid aortic valve', 'tensile testing', 'aortic strength', 'aortic rupture'], 'conditions': ['Aneurysm Aortic', 'Aneurysm Aortic Root']}, 'referencesModule': {'references': [{'pmid': '26356765', 'type': 'RESULT', 'citation': 'Ferrara A, Morganti S, Totaro P, Mazzola A, Auricchio F. Human dilated ascending aorta: Mechanical characterization via uniaxial tensile tests. J Mech Behav Biomed Mater. 2016 Jan;53:257-271. doi: 10.1016/j.jmbbm.2015.08.021. Epub 2015 Aug 20.'}, {'pmid': '21616506', 'type': 'RESULT', 'citation': 'Khanafer K, Duprey A, Zainal M, Schlicht M, Williams D, Berguer R. Determination of the elastic modulus of ascending thoracic aortic aneurysm at different ranges of pressure using uniaxial tensile testing. J Thorac Cardiovasc Surg. 2011 Sep;142(3):682-6. doi: 10.1016/j.jtcvs.2010.09.068. Epub 2011 May 25.'}, {'pmid': '12683565', 'type': 'RESULT', 'citation': 'Vorp DA, Schiro BJ, Ehrlich MP, Juvonen TS, Ergin MA, Griffith BP. Effect of aneurysm on the tensile strength and biomechanical behavior of the ascending thoracic aorta. Ann Thorac Surg. 2003 Apr;75(4):1210-4. doi: 10.1016/s0003-4975(02)04711-2.'}, {'pmid': '34496896', 'type': 'RESULT', 'citation': "Surman TL, Abrahams JM, Manavis J, Finnie J, O'Rourke D, Reynolds KJ, Edwards J, Worthington MG, Beltrame J. Histological regional analysis of the aortic root and thoracic ascending aorta: a complete analysis of aneurysms from root to arch. J Cardiothorac Surg. 2021 Sep 8;16(1):255. doi: 10.1186/s13019-021-01641-5."}, {'pmid': '35134955', 'type': 'RESULT', 'citation': 'Dong H, Liu M, Qin T, Liang L, Ziganshin B, Ellauzi H, Zafar M, Jang S, Elefteriades J, Sun W. Engineering analysis of aortic wall stress and root dilatation in the V-shape surgery for treatment of ascending aortic aneurysms. Interact Cardiovasc Thorac Surg. 2022 Jun 1;34(6):1124-1131. doi: 10.1093/icvts/ivac004.'}, {'pmid': '29262774', 'type': 'RESULT', 'citation': 'Plonek T, Zak M, Burzynska K, Rylski B, Gozdzik A, Kustrzycki W, Beyersdorf F, Jasinski M, Filipiak J. The combined impact of mechanical factors on the wall stress of the human ascending aorta - a finite elements study. BMC Cardiovasc Disord. 2017 Dec 20;17(1):297. doi: 10.1186/s12872-017-0733-9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to analyse the resected portion of aneurysmatic ascending aorta in order to assess its strength to rupture, standardise the various measurements performed within the lab and try to correlate these qualitative results with quantitative results (regarding aortic diameter, valve morphology and aortic wall thickness).', 'detailedDescription': "The aortic wall is subjected to mechanical stresses in radial, circumferential, and longitudinal directions. The amount of these shear stresses varies with the distribution of velocity across the vessel lumen and with local vessel geometry.\n\nDiseases affecting the thoracic aorta can be categorized into acute and chronic. Chronic aortic pathologies are chronic aortic dissections and aortic aneurysms.\n\nToday, there are computational tools available to permit the calculation of stresses of the aortic wall.\n\nFor the above-mentioned reasons, this study becomes of extreme interest as it may be capable of further assessing the mechanical properties of the dilated aortic tissue, its' strength to rupture and stiffness, in order to provide an overview of the fragility of ascending aortic aneurysms. This parameter, associated to the diameter of the pathological aorta, may provide an additional tool regarding the clinical history of patients and insight concerning surgical indication.\n\nMatter of factly, knowing the risk of rupture based on diameter may have strong implications on the preoperative evaluation of patients and the decision-making process."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac surgery for ascending or aortic root aneurysms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery for either aortic root and/or ascending aortic aneurysms; • Patients that have received, understood and signed the written informed consent for this study.\n\nExclusion Criteria:\n\n* Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.'}, 'identificationModule': {'nctId': 'NCT07453251', 'acronym': 'STORM', 'briefTitle': 'Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Strength Tracking From Wall Tichness Over Aortic Biomechanics', 'orgStudyIdInfo': {'id': 'CET 316-2025'}}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Sala, MD', 'role': 'CONTACT', 'email': 'alessandra.sala@grupposandonato.it', 'phone': '+39 0252774961'}, {'name': 'Alessandra Sala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the investigators not planning to share IPD, because anonymised data might be used for future scientific publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac Surgeon', 'investigatorFullName': 'Alessandra Sala', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}