Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05786274

Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiac Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cerebral autoregulation monitoring

Diagnostic Test

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

Primary outcomes

  1. Autoregulation index (ARI)

    Time frame: 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.

  2. Cerebral Oxymetry index (CoX)

    Time frame: 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

  3. number of patients developing cerebrovascular adverse events

    Time frame: 36 months

    The number of patients developing cerebrovascular adverse events will be assessed by the presence of positive lesions as detected by DW-MRI.

Secondary outcomes

  1. Baroreflex sensitivity

    Time frame: 36 months

    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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Collaborators

  • University of Milan

Registry information

Official study title

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

Acronym: PASCAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.