Predicting brain complications after heart surgery
Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices
NA · IRCCS Policlinico S. Donato · NCT05786274
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato (other) |
| Locations | 1 site (San Donato Milanese, Milan) |
| Trial ID | NCT05786274 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing cardiac surgery and have a normal sinus rhythm.
Not a fit: Patients under 18 years old, those with autonomic disorders, or those requiring carotid interventions may not benefit from this study.
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 performed: While similar studies have explored cerebral autoregulation in cardiac surgery, this specific predictive modeling approach is relatively novel.
Eligibility criteria
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 this trial is running
San Donato Milanese, Milan
- 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
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.
Conditions: Cardiac Disease, cerebral autoregulation, cardiopulmonary bypass, stroke