Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Major Cardiac surgery.
- Who it may be relevant to
- Registry conditions: Cardiac Disease, Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Major Cardiac surgery
From a clinical perspective, MANCAVA will especially target neuro-cardiovascular health and mood disorders such as depression
Primary outcome measures
- Autoregulation index (ARI) [Time frame: 24 months]
- number of patients developing depression [Time frame: 24 months]
- Baroreflex sensitivity [Time frame: 24 months]
- Cortical activity [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- age older than 18 years
- spontaneous sinus rhythm
- signed informed consent
- indication to heart surgery
Exclusion criteria
- age lower than 18 years
- absence of sinus rhythm
- pregnancy
- impossibility of informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- IRCCS Policlinico San Donato — San Donato Milanese
Identifiers
NCT: NCT06294119 · MANCAVA · 2022SLB5MX