Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Cardiac Disease

• Registration Number: NCT05786274
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-27
• Study Start: 2023-04-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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.
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.

Secondary Outcome Measures

Name	Time	Method
Baroreflex sensitivity	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.

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy