Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT05706532
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2023-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular and Cerebrovascular Control in Healthy Subjects
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': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the state and interactions of autonomic function and cerebrovascular control', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autonomic nervous system', 'heart rate variability', 'cerebral autoregulation', 'peripheral resistances'], 'conditions': ['Healthy', 'Autonomic Nervous System', 'Cerebral Autoregulation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.\n\nTo this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.\n\nThe interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18\n* sinus rhythm\n* informed consent signed\n\nExclusion Criteria:\n\n* age \\<18\n* presence of autonomic nervous system diseases or dysfunctions'}, 'identificationModule': {'nctId': 'NCT05706532', 'acronym': 'CardioSan', 'briefTitle': 'Cardiovascular and Cerebrovascular Control in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Cardiovascular and Cerebrovascular Control in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'CardioSan'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': '60 healthy subjects; age \\>18; sinus rhythm; absence of autonomic diseases or dysfunctions.', 'interventionNames': ['Diagnostic Test: active standing']}], 'interventions': [{'name': 'active standing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Data are acquired with patients resting in supine position for 10 minutes and for 10 minutes during active standing', 'armGroupLabels': ['Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vlasta Bari, PhD', 'role': 'CONTACT', 'email': 'vlasta.bari@grupposandonato.it', 'phone': '+390252774381'}, {'name': 'Marco Ranucci, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vlasta Bari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'centralContacts': [{'name': 'Vlasta Bari, PhD', 'role': 'CONTACT', 'email': 'vlasta.bari@grupposandonato.it', 'phone': '+390252774381'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, PhD', 'investigatorFullName': 'Vlasta Bari', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}