Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

NCT05786274 | Recruiting DMC

• 2 other identifiers: PASCALGR-2021-12372037
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease

Keywords

cerebral autoregulation; cardiopulmonary bypass; stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Baroreflex sensitivity

  36 months

Study Arms (1)

Cardiac surgery with cardiopulmonary bypass patients

OTHER

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

Interventions

Cerebral autoregulation monitoring DIAGNOSTIC_TEST

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

Cardiac surgery with cardiopulmonary bypass patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age older than 18 years
• spontaneous sinus rhythm
• no pregnancy
• signed informed consent

You may not qualify if:

• age lower than 18 years
• absence of sinus rhythm
• autonomic disorders
• concomitant carotid intervention
• reintervention
• contraindication to MRI
• pregnancy
• impossibility of informed consent

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• University of Milan: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Stroke

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Central Study Contacts

Vlasta Bari, Ph.D.

CONTACT

0252774381; vlasta.bari@grupposandonato.it

Giacomo Bortolussi, M.D.

CONTACT

0252774754; giacomo.bortolussi@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)