Predicting Cerebrovascular Adverse Events Post Cardiac Surgery (PASCAL)

San Donato Group (GSD)

Status: Enrolling

Conditions: Cardiac Disease

Treatments: Diagnostic Test: Cerebral autoregulation monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05786274

PASCAL

GR-2021-12372037 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Cardiac surgery with cardiopulmonary bypass patients

Other group

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.

Treatment:

Diagnostic Test: Cerebral autoregulation monitoring