Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Disease

Intervention / Treatment
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* Diagnostic Test: Cerebral autoregulation monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiac surgery with cardiopulmonary bypass patients<br>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<br>* Perioperative characterization of cerebral autoregulation and autonomic function; characterization of adverse events after surgery<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral autoregulation, cardiopulmonary bypass, stroke