Measuring how the brain, autonomic system, and blood vessels interact
Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Trial ID | NCT06294119 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Donato Milanese, Milan
- IRCCS Policlinico San Donato — San Donato Milanese, Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.