Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT05703893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2023-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D035583', 'term': 'Rare Diseases'}, {'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 139}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Supine resting (REST) and active standing (STAND)', 'timeFrame': '18 months', 'description': 'Baroreflex sensitivity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic Aneurysms', 'Heart rate Variability', 'Autonomic Nervous System'], 'conditions': ['Rare Diseases', 'Aortic Aneurysm, Thoracic']}, 'descriptionModule': {'briefSummary': 'The goal of this observational cross-sectional study is to learn about vagal features in patients with syndromic and non-syndromic TAA. The main question it aims to answer is to highlight a functional condition that could help stratify patients with TAA on the risk of aortic complications.\n\nParticipant will take part by standing in supine position for 10 minutes and during active standing for 10 minutes. In this period of time, it will be possible to acquire the signals continuously and non invasively through recorded non-invasive blood pressure and piezoelectric sensor breathing belt.', 'detailedDescription': 'Changes in blood pressure (BP) are tightly controlled by a neural surveillance system that triggers changes in response to heart rate, vascular tone, and respiration.\n\nTherefore, studies in literature have investigated the regulatory effects of the sympathetic system on the tone of the vessels as well as on the BP, but further analysis are needed in order to describe its potential impact on the structure of the aortic wall and, in particular, its potential implications on aneurysms and risk of aortic dissections.\n\nConsidering that, in the population with TAA, the neurovegetative pattern influences the responses to different stressors (environmental, occupational and emotional) and also acts on the BP, which represents a risk factor for the TAA population, its analysis would allow to identify attitudes and behavioral predispositions and therefore response to stressors.\n\nThe non-invasive analysis of sympatho-adrenergic patterns could help to highlight a functional condition related to the "environmental stressors" which could help to stratify patients with TAA based on the level of pathological reactivity with effects on risk of aortic complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic, hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-65 years with syndromic and nonsyndromic TAA;\n* Signed informed consent;\n* Patients on regular pharmacological prophylaxis (with Losartan) or naïve patients with a first diagnosis\n\nExclusion Criteria:\n\n* Acute and chronic inflammatory diseases such as: liver disease, chronic renal insufficiency (creatinine \\> 1.5 mg/dl) and diseases affecting the thyroid system.'}, 'identificationModule': {'nctId': 'NCT05703893', 'acronym': 'IPaNeMA', 'briefTitle': 'Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Investigation of the Neurovegetative Pattern in the Adult Population With Thoracic Aortic Aneurysms (AAT)', 'orgStudyIdInfo': {'id': 'IPaNeMA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Syndromic TAA', 'description': 'Patients presenting either clinical or genetic phenotype referring to a syndrome related to Thoracic Aortic Aneurysms', 'interventionNames': ['Diagnostic Test: Supine resting (REST) and active standing (STAND)']}, {'label': 'Non-syndromic TAA', 'description': 'Patients presenting Thoracic Aortic Aneurysms', 'interventionNames': ['Diagnostic Test: Supine resting (REST) and active standing (STAND)']}], 'interventions': [{'name': 'Supine resting (REST) and active standing (STAND)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Analysis of baroreflex sensitivity', 'armGroupLabels': ['Non-syndromic TAA', 'Syndromic TAA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'collaborators': [{'name': 'Politecnico di Milano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alessandro Pini', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}