protocolSection identificationModule nctId: NCT06294119, orgStudyIdInfo id: MANCAVA, secondaryIdInfos id: 2022SLB5MX, type: OTHER_GRANT, domain: Italian Ministry of Research, briefTitle: Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2026-02-08, completionDateStruct date: 2026-02-08, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: IRCCS Policlinico S. Donato, class: OTHER, descriptionModule briefSummary: MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states., conditionsModule conditions: Cardiac Disease, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Major Cardiac surgery, outcomesModule primaryOutcomes measure: Autoregulation index (ARI), primaryOutcomes measure: number of patients developing depression, primaryOutcomes measure: Baroreflex sensitivity, primaryOutcomes measure: Cortical activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Policlinico San Donato, status: RECRUITING, city: San Donato Milanese, state: Milan, zip: 20097, country: Italy, contacts name: Vlasta Bari, PhD, role: CONTACT, phone: +390252774381, email: vlasta.bari@grupposandonato.it, contacts name: Pavandeep Singh, role: CONTACT, email: pavandeep.singh@grupposandonato.it, contacts name: Marco Ranucci, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Vlasta Bari, PhD, role: SUB_INVESTIGATOR, contacts name: Alberto Porta, PhD, role: SUB_INVESTIGATOR, contacts name: Francesca Gelpi, Ms, role: SUB_INVESTIGATOR, contacts name: Beatrice Cairo, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.41047, lon: 9.26838, hasResults: False