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Predicting Cerebrovascular Adverse Events Post Cardiac Surgery (PASCAL)

Primary Purpose

Cardiac Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cerebral autoregulation monitoring
Sponsored by
IRCCS Policlinico S. Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Disease focused on measuring cerebral autoregulation, cardiopulmonary bypass, stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vlasta Bari

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cardiac surgery with cardiopulmonary bypass patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Cerebral autoregulation during cardiac surgery with cardiopulmonary bypass
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
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
to develop a predictive model of postoperative cerebrovascular outcome based on cerebral autoregulation and autonomic function indices

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
IRCCS Policlinico S. Donato
Collaborators
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT05786274
Brief Title
Predicting Cerebrovascular Adverse Events Post Cardiac Surgery
Acronym
PASCAL
Official Title
Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato
Collaborators
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
cerebral autoregulation, cardiopulmonary bypass, stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac surgery with cardiopulmonary bypass patients
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cerebral autoregulation monitoring
Intervention Description
Perioperative characterization of cerebral autoregulation and autonomic function; characterization of adverse events after surgery
Primary Outcome Measure Information:
Title
Cerebral autoregulation during cardiac surgery with cardiopulmonary bypass
Description
to assess cerebral autoregulation and autonomic control within the different phases of the intervention
Time Frame
36 months
Title
Comparison of cerebral autoregulation measures derived from transcranial Doppler device and near infrared spectroscopy
Description
to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy
Time Frame
36 months
Title
Predictive model of postoperative cerebrovascular outcome
Description
to develop a predictive model of postoperative cerebrovascular outcome based on cerebral autoregulation and autonomic function indices
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vlasta Bari, Ph.D.
Phone
0252774381
Email
vlasta.bari@grupposandonato.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giacomo Bortolussi, M.D.
Phone
0252774754
Email
giacomo.bortolussi@grupposandonato.it
Facility Information:
Facility Name
Vlasta Bari
City
San Donato Milanese
State/Province
Milan
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

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