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

NCT06294119 | Recruiting DMC

• 2 other identifiers: MANCAVA2022SLB5MX
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Depression

Outcome Measures

Primary Outcomes (4)

• 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.

  24 months

• number of patients developing depression

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

  24 months

• 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.

  24 months

• Cortical activity

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

  24 months

Study Arms (1)

Cardiac surgery

OTHER

An experimental setup will be devised for the simultaneous monitoring and recording of EEG, ECG, AP, and R together with CBF in patients scheduled for major cardiac surgery. Recording sessions will take place 1 day before (PRE) and within 7 days after (POST) surgery. The experimental protocol including physiological data recordings includes three sessions lasting 10 minutes each: a session at resting state in supine position, a session during autonomic challenge obtained via active standing evoking reflex sympathetic activation, and a session of emotional elicitation via the administration of videos. The overall duration of the experiment is therefore 30 minutes in PRE and POST. A total of 40 short video clips of the duration of 15 seconds each will be presented to a total of 80 voluteers will be recruited for the MANCAVA study.

Procedure: Major Cardiac surgery

Interventions

Major Cardiac surgery PROCEDURE

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

Cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age older than 18 years
• spontaneous sinus rhythm
• signed informed consent
• indication to heart surgery

You may not qualify if:

• age lower than 18 years
• absence of sinus rhythm
• pregnancy
• impossibility of informed consent

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Depression

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: September 30, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)