Predicting Cerebrovascular Adverse Events Post Cardiac Surgery (PASCAL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: Diagnostic test: Cerebral autoregulation monitoring

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vlasta Bari, Ph.D.; Phone Number: 0252774381; Email: vlasta.bari@grupposandonato.it
• Study Contact Backup: Name: Giacomo Bortolussi, M.D.; Phone Number: 0252774754; Email: giacomo.bortolussi@grupposandonato.it

Study Locations

• Italy
  • Milan
    • San Donato Milanese, Milan, Italy, 20097
      • Recruiting
      • IRCCS Policlinico San Donato
      • Contact: Vlasta Bari, PhD; Phone Number: +390252774381; Email: vlasta.bari@grupposandonato.it
      • Sub-Investigator: Beatrice Cairo, PhD
      • Sub-Investigator: Moreno Zanardo, PhD
      • Sub-Investigator: Giacomo Bortolussi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baroreflex sensitivity	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.	36 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Collaborators: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: stroke; cardiopulmonary bypass; cerebral autoregulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: PASCAL; GR-2021-12372037 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No