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NCT Number: NCT06294119

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

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.

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Key information

Conditions

Cardiac Disease Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Major Cardiac surgery

Procedure

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

Primary outcomes

  1. Autoregulation index (ARI)

    Time frame: 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.

  2. number of patients developing depression

    Time frame: 24 months

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

  3. Baroreflex sensitivity

    Time frame: 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.

  4. Cortical activity

    Time frame: 24 months

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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 5, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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