Predicting brain complications after heart surgery
Official title: Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices
Run by IRCCS Policlinico S. Donato · NCT05786274 · Data updated 2026-11-12
This study is testing two ways to measure how well the brain controls blood flow during heart surgery to see if it can help predict the risk of complications like strokes afterward.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Status | Recruiting |
| Started | April 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT05786274 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are undergoing cardiac surgery and have a normal sinus rhythm.
✕Probably not a fit
Patients under 18 years old, those with autonomic disorders, or those requiring carotid interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate how well the brain regulates blood flow during different phases of cardiac surgery that involves cardiopulmonary bypass. It will compare two methods of measuring cerebral autoregulation: one using a transcranial Doppler device to assess blood flow velocity and another using near infrared spectroscopy. The ultimate goal is to develop a predictive model for postoperative cerebrovascular outcomes, such as strokes, based on the data collected during the surgery.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for cerebrovascular events after cardiac surgery, allowing for better preventive measures.
How similar studies have gone: While similar studies have explored cerebral autoregulation in cardiac surgery, this specific predictive modeling approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age older than 18 years * spontaneous sinus rhythm * no pregnancy * signed informed consent Exclusion Criteria: * age lower than 18 years * absence of sinus rhythm * autonomic disorders * concomitant carotid intervention * reintervention * contraindication to MRI * pregnancy * impossibility of informed consent
Where it's running
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IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy Recruiting
Study contacts
- Study coordinator: Vlasta Bari, Ph.D.
- Email: vlasta.bari@grupposandonato.it
- Phone: 0252774381
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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.