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

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Cardiac Disease; Depression

Treatments: Procedure: Major Cardiac surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06294119

2022SLB5MX (Other Grant/Funding Number)

MANCAVA

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Cardiac surgery

Other group

Description:

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.

Treatment:

Procedure: Major Cardiac surgery