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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Policlinico S. Donato

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

age older than 18 years

spontaneous sinus rhythm

signed informed consent

indication to heart surgery

Disqualifiers

age lower than 18 years

absence of sinus rhythm

pregnancy

impossibility of informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Major Cardiac surgery

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Cardiac surgeryOther 1 intervention

Trial outcomes

Primary outcomes

1

Autoregulation index (ARI)

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.

Time frame
24 months
2

number of patients developing depression

The number of patients developing depression will be assessed by the results of psychometric tests

Time frame
24 months
3

Baroreflex sensitivity

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.

Time frame
24 months
4

Cortical activity

Power of EEG in Alpha and Beta band will be measured in square microvolt

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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