Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay

Condition(s) studied

Investigational drug(s) / intervention(s)

Major Cardiac surgery: From a clinical perspective, MANCAVA will especially target neuro-cardiovascular health and mood disorders such as depression

Study summary

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.

Eligibility

Primary outcome measure(s)

• Autoregulation index (ARI) — 24 months
  ARI is an index describing the state of cerebral autoregulation from mean cerebral blood velocity and mean arterial pressure. It ranges between 1 and 9. ARI\>4 means working autoregulation. ARI\<4 means impaired autoregulation. It will be computed for all participants in PRE and POST.
• number of patients developing depression — 24 months
  The number of patients developing depression will be assessed by the results of psychometric tests
• Baroreflex sensitivity — 24 months
  Baroreflex sensitivity will be measured in ms/mmHg. A higher value means a better baroreflex regulation. It will be computed in all participants in PRE and POST surgery.
• Cortical activity — 24 months
  Power of EEG in Alpha and Beta band will be measured in square microvolt

Trial sites (1)

More IRCCS Policlinico S. Donato trials in Italy

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