PASCAL: Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

Sponsor

IRCCS Policlinico S. Donato (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786274

Collaborator

University of Milan (Other)

104

Enrollment

Location

Arm

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Diagnostic Test: Cerebral autoregulation monitoring	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Cardiac surgery with cardiopulmonary bypass patients Patients will be enrolled before cardiac surgery with cardiopulmonary bypass (CPB) and monitored until after the surgery. Patients enrolled will undergo diffusion weighted magnetic resonance imaging and will be administered with cognitive tests one day before surgery and within one week after surgery. Cerebral blood flow velocity as derived from transcranial Doppler recordings will be acquired from the middle cerebral artery synchronously with arterial pressure, invasively derived from the radial artery, and with the electrocardiogram as derived from patient's monitor. Signals will be acquired before anesthesia induction (BASAL), after anesthesia induction and intubation of the chest (ANESTH) and during CPB (CPB). Each acquisition will last at least 5 minutes and will be prolonged to the maximum possible length in keeping with clinical scheduling. Partial pressure of carbon dioxide and other clinical parameters will be acquired too during the intervention.	Diagnostic Test: Cerebral autoregulation monitoring Perioperative characterization of cerebral autoregulation and autonomic function; characterization of adverse events after surgery

Arm

Intervention/Treatment

Other: Cardiac surgery with cardiopulmonary bypass patients

Patients will be enrolled before cardiac surgery with cardiopulmonary bypass (CPB) and monitored until after the surgery. Patients enrolled will undergo diffusion weighted magnetic resonance imaging and will be administered with cognitive tests one day before surgery and within one week after surgery. Cerebral blood flow velocity as derived from transcranial Doppler recordings will be acquired from the middle cerebral artery synchronously with arterial pressure, invasively derived from the radial artery, and with the electrocardiogram as derived from patient's monitor. Signals will be acquired before anesthesia induction (BASAL), after anesthesia induction and intubation of the chest (ANESTH) and during CPB (CPB). Each acquisition will last at least 5 minutes and will be prolonged to the maximum possible length in keeping with clinical scheduling. Partial pressure of carbon dioxide and other clinical parameters will be acquired too during the intervention.

Diagnostic Test: Cerebral autoregulation monitoring

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

Outcome Measures

Primary Outcome Measures

Cerebral autoregulation during cardiac surgery with cardiopulmonary bypass [36 months]
to assess cerebral autoregulation and autonomic control within the different phases of the intervention
Comparison of cerebral autoregulation measures derived from transcranial Doppler device and near infrared spectroscopy [36 months]
to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy
Predictive model of postoperative cerebrovascular outcome [36 months]
to develop a predictive model of postoperative cerebrovascular outcome based on cerebral autoregulation and autonomic function indices

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vlasta Bari	San Donato Milanese	Milan	Italy	20097

Sponsors and Collaborators

IRCCS Policlinico S. Donato
University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vlasta Bari, Principal Investigator, IRCCS Policlinico S. Donato

ClinicalTrials.gov Identifier:

NCT05786274

Other Study ID Numbers:

PASCAL
GR-2021-12372037

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vlasta Bari, Principal Investigator, IRCCS Policlinico S. Donato

cerebral autoregulation

cardiopulmonary bypass

stroke

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of Mar 27, 2023