Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-31 @ 2:38 AM
Study NCT ID:
NCT05715203
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aortic Stiffness in Patients With Genetic Aortopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D035583', 'term': 'Rare Diseases'}, {'id': 'D000094625', 'term': 'Aneurysm, Ascending Aorta'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse Wave Velocity', 'timeFrame': '18 months', 'description': "Statistic analysis will be performed using the Statistical Package for Social Science (SPSS for Windows; v20.0; SPSS, Chicago, Illinois, USA). Continuous variables will be expressed as mean ± Standard Deviation, while qualitative variables will be expressed as a percentage. Qualitative data will be compared using Fisher's test or Pearson's χ2 test, when appropriate. Continuous variables by t-test or analysis of variance normalized for covariates. Continuous variables will be correlated by simple or multiple linear regression"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arterial stiffness', 'Ascending aortic aneurysm', 'pulse wave velocity'], 'conditions': ['Rare Diseases', 'Aortic Stiffness', 'Connective Tissue Defect']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), either syndromic or non-syndromic. The main questions it aims to answer are:\n\n* Stratification of aortic risk based on arterial stiffness; Compare measurements with morphological and haemodynamic features of the ascending thoracic aorta.\n\nParticipants will be asked to undergo non-invasive evaluation of blood pressure and arterial stiffness.', 'detailedDescription': 'Recent studies have highlighted the role played by the aorta and the great arteries in the regulation of the blood pressure (BP) and peripheral blood flow. Similarly, the structural and functional alteration of the aortic wall having a genetic cause is highly associated with the onset of aneurysms, especially of the ascending aorta, for which it is essential to monitor the aortic stiffness, which is detectable through a non-invasive and non-radioactive method such as Pulse Wave Velocity (PWV). Despite literature studies correlating PWV in MFS, few evaluations of aortic stiffness in patients with syndromic TAA have been done and its potential correlations with other aneurysm markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ascending aortic aneurysms currently in follow.up at Cardiovascular Gentic Centre, IRCCS Policlinico San Donato.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with AAT, either syndromic or non syndromic;\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients with early menopause and/or osteoporosis, rheumatic heart disease and active malignant tumours;\n* Patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system;\n* Seropositivity to HIV, HCV, HBsAg and SARS-CoV-2;\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05715203', 'acronym': 'PULSEWAVE', 'briefTitle': 'Aortic Stiffness in Patients With Genetic Aortopathies', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis', 'orgStudyIdInfo': {'id': 'Pulse Wave'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Syndromic TAA', 'description': 'Subjets with clinical or genetic diagnosis of syndromic thoracic aortic aneurysms', 'interventionNames': ['Device: Pulsotonometry']}, {'label': 'Non-syndromic TAA', 'description': 'Subjets without clinical or genetic diagnosis of syndromic thoracic aortic aneurysms', 'interventionNames': ['Device: Pulsotonometry']}], 'interventions': [{'name': 'Pulsotonometry', 'type': 'DEVICE', 'description': 'Evaluation of arterial stiffness', 'armGroupLabels': ['Non-syndromic TAA', 'Syndromic TAA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Pini, MD', 'role': 'CONTACT', 'email': 'alessandro.pini@grupposandonato.it', 'phone': '+390252774705'}], 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'centralContacts': [{'name': 'Alessandro Pini, MD', 'role': 'CONTACT', 'email': 'alessandro.pini@grupposandonato.it', 'phone': '+390252774705'}], 'overallOfficials': [{'name': 'Alessandro Pini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alessandro Pini', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}