NCT Number: NCT05786274
The aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Donato Milanese, Milan, 20097, Italy
Location status: Recruiting
Beatrice Cairo, PhD
SUB_INVESTIGATOR
Giacomo Bortolussi, MD
SUB_INVESTIGATOR
Moreno Zanardo, PhD
SUB_INVESTIGATOR
Vlasta Bari, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Perioperative characterization of cerebral autoregulation and autonomic function; characterization of adverse events after surgery
Time frame: 36 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 BASAL, ANESTH, CPB.
Time frame: 36 months
CoX is an index describing the state of cerebral autoregulation derived from NIRS and mean arterial pressure. It ranges between 0 and 1. CoX = 1 means perfect coupling. Cox=0 means uncoupling. It will be computed for all participants in BASAL, ANESTH, CPBasurements derived from near infrared spectroscopy
Time frame: 36 months
The number of patients developing cerebrovascular adverse events will be assessed by the presence of positive lesions as detected by DW-MRI.
Time frame: 36 months
Baroreflex sensitivity will be measured in ms/mmHg. A higher value means a better baroreflex regulation. It will be computed in all participants during BASAL, ANESTH, CPB.
Contact information is provided by the study sponsor or research team.
Giacomo Bortolussi, M.D.
CONTACT
Vlasta Bari, Ph.D.
CONTACT
IRCCS Policlinico S. Donato
Other
Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices
Acronym: PASCAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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