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Recruiting Not applicable

Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

NCT05786274 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-04-01
Last updated
2026-07-06

Condition(s) studied

Cardiac Disease

Investigational drug(s) / intervention(s)

Cerebral autoregulation monitoring

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Autoregulation index (ARI) — 36 months
    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.
  • Cerebral Oxymetry index (CoX) — 36 months
    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
  • number of patients developing cerebrovascular adverse events — 36 months
    The number of patients developing cerebrovascular adverse events will be assessed by the presence of positive lesions as detected by DW-MRI.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Policlinico San Donato San Donato Milanese Milan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05786274 on ClinicalTrials.gov ↗ ← All trials in Italy