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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06294119
Enrollment
80
Registered
2024-03-05
Start date
2025-09-30
Completion date
2029-02-28
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Depression

Brief 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.

Interventions

PROCEDUREMajor Cardiac surgery

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

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Autoregulation index (ARI)24 monthsARI 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 depression24 monthsThe number of patients developing depression will be assessed by the results of psychometric tests
Baroreflex sensitivity24 monthsBaroreflex 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 activity24 monthsPower of EEG in Alpha and Beta band will be measured in square microvolt

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026