Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

Cardiac Disease Clinical Trial

— PASCAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786274
• Other study ID #: PASCAL
• Secondary ID: GR-2021-12372037
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Vlasta Bari, Ph.D.
• Phone: 0252774381
• Email: vlasta.bari[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Primary	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	36 months
Primary	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.	36 months
Secondary	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.	36 months