Measuring how the brain, autonomic system, and blood vessels interact
Official title: Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay
Run by IRCCS Policlinico S. Donato · NCT06294119 · Data updated 2026-11-12
This project tests new mathematical and monitoring methods to measure how brain activity, autonomic function, and blood flow interact in adults scheduled for major heart surgery, with the goal of linking these patterns to depression and cardiac outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | February 28, 2029 |
| Study ends | February 28, 2029 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT06294119 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 who are in spontaneous sinus rhythm, can give informed consent, and have an indication for major cardiac surgery are the intended participants.
✕Probably not a fit
People under 18, pregnant patients, those without sinus rhythm or unable to give informed consent, and individuals not undergoing cardiac surgery are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The protocol collects simultaneous physiological signals related to cortical activity, autonomic function, and cerebrovascular autoregulation in adults undergoing major cardiac surgery and applies new multivariate, time-varying mathematical tools to characterize their interactions. Data will combine recordings such as EEG or other cortical measures, heart rhythm and variability, and cerebral blood flow or blood pressure dynamics to model cross-system links. The methods aim to identify patterns that connect brain and reflex function to heart and circulatory outcomes and to mood symptoms. Results will be used to propose integrated biomarkers that bridge physiological and psychological dimensions of depression and cardiac risk.
Why it matters
Potential benefit: If successful, this work could improve understanding of how brain–autonomic–vascular interactions contribute to depression and heart disease and support more personalized monitoring or treatment strategies.
How similar studies have gone: Previous research has linked autonomic and cerebrovascular measures to mood and cardiac outcomes, but applying multivariate, time-varying mathematical tools to map whole-body interactions is largely novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.