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Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

ConditionCardiac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Policlinico S. Donato

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age older than 18 years

spontaneous sinus rhythm

no pregnancy

signed informed consent

Disqualifiers

age lower than 18 years

absence of sinus rhythm

autonomic disorders

concomitant carotid intervention

Trial design

Design model

Single group

Treatments tested in this trial

  • Cerebral autoregulation monitoring

    Diagnostic test

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

Treatment groups

104 Participants
are divided into 1 treatment group
Group A: Cardiac surgery with cardiopulmonary bypass patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
36 months
2

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

Time frame
36 months
3

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.

Time frame
36 months

Secondary outcomes

1

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.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Policlinico S. Donato

Lead sponsor

University of Milan

Collaborator

Source ClinicalTrials.gov
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