Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05786274

Acronym

PASCAL

Enrollment

104

Registered

2023-03-27

Start date

2023-04-01

Completion date

2026-12-31

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

cerebral autoregulation, cardiopulmonary bypass, stroke

Brief summary

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.

Interventions

DIAGNOSTIC_TESTCerebral autoregulation monitoring

Perioperative characterization of cerebral autoregulation and autonomic function; characterization of adverse events after surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Autoregulation index (ARI)	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.
Cerebral Oxymetry index (CoX)	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
number of patients developing cerebrovascular adverse events	36 months	The number of patients developing cerebrovascular adverse events will be assessed by the presence of positive lesions as detected by DW-MRI.

Secondary

Measure	Time frame	Description
Baroreflex sensitivity	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.

Countries

Italy

Contacts

CONTACTVlasta Bari, Ph.D.

vlasta.bari@grupposandonato.it0252774381

CONTACTGiacomo Bortolussi, M.D.

giacomo.bortolussi@grupposandonato.it0252774754

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026