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

March 23, 2026 updated by: Marco Ranucci, IRCCS Policlinico S. Donato

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • San Donato Milanese, Milan, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
        • Sub-Investigator:
          • Vlasta Bari, PhD
        • Principal Investigator:
          • Marco Ranucci, MD
        • Sub-Investigator:
          • Alberto Porta, PhD
        • Contact:
        • Sub-Investigator:
          • Beatrice Cairo, PhD
        • Contact:
        • Sub-Investigator:
          • Francesca Gelpi, Ms

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cardiac surgery
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
From a clinical perspective, MANCAVA will especially target neuro-cardiovascular health and mood disorders such as depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
number of patients developing depression
Time Frame: 24 months
The number of patients developing depression will be assessed by the results of psychometric tests
24 months
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.
24 months
Cortical activity
Time Frame: 24 months
Power of EEG in Alpha and Beta band will be measured in square microvolt
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2025

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANCAVA
  • 2022SLB5MX (Other Grant/Funding Number: Italian Ministry of Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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