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Recruiting NCT05786274

Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

No phase Interventional Cardiac Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cerebral autoregulation monitoring.
Who it may be relevant to
Registry conditions: Cardiac Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test Cerebral autoregulation monitoring
    Perioperative characterization of cerebral autoregulation and autonomic function; characterization of adverse events after surgery

Primary outcome measures

  • Autoregulation index (ARI) [Time frame: 36 months]
  • Cerebral Oxymetry index (CoX) [Time frame: 36 months]
  • number of patients developing cerebrovascular adverse events [Time frame: 36 months]
Secondary outcome measures (1)
  • Baroreflex sensitivity [Time frame: 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • IRCCS Policlinico San Donato — San Donato Milanese

Identifiers

NCT: NCT05786274 · PASCAL · GR-2021-12372037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗