Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

Cognitive Impairment Clinical Trial

Official title:

Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03907943
• Other study ID #: 17/2019
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2022
• Source: Semmelweis University Heart and Vascular Center
• Contact: Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia
• Phone: +36203304584
• Email: andi_szekely[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of cognitive function in patients undergoing elective carotid endarterectomy

Classical treatment for ICA stenosis is carotid endarterectomy (CEA), which has been proven effective in preventing future stroke as well as improving cerebral perfusion. However, the influence of CEA on cognition is less defined, it remains unclear whether CEA can improve cognitive function. A change in cognition is one of the most threatening diseases of recent years, cognitive impairment significantly impacts patients, families, and healthcare system.

The difference in the cognitive outcome may be accounted for microembolic events and adverse changes in haemodynamic circumstances.

The aim of our study is to identify those factors what may have role in the postoperative cognitive decline.

The study was approved by the Ethical Committee of the university ( SE RKEB: 17/2019) and written informed consent will be obtained from all patients.

The investigators intend to enroll patient aged more than 18 years undergoing elective carotid endarterectomy at our hospital ( Semmelweis University Heart and Vascular Center). Exclusion criterion included young age (less than 18 years), incapacity and urgent surgery. The investigators would like to register at least 100-150 patients in our study.

Most relevant anamnestic dates, the results of the laboratory and radiological reports will be recorded. Cognitive functions will be assessed one day before, one day and six month after the surgery using MMSE and a questionnaire called Frailty to characterize beside cognitive function the physiological reserve of the patients too.

The investigators manage patients undergoing carotid endarterectomy with general anaesthesia, using inhaled or total intravenous agents.

During the operation the investigators record beside the routine monitoring (intraarterial blood pressure, ECG, oxygen saturation, EtCO2, MAC) the cerebral tissue oxygen saturation using a near-infrared cerebral oximeter (Invos Cerebral/Somatic Oximeter) and the activity of the brain using GE Entropy Module.

The investigators would like to register the changes in the haemodynamic and cerebral condition and compare these results against the clinical outcome and the changes of the questionnaires.

Statistical analyses will be performed using Statistical Package for the Social Sciences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged more than 18 years, undergoing elective carotid endarterectomy

Exclusion Criteria:

• younger than 18 years, incapacity, urgent surgery, lack of consent

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Procedure:
• carotid endarterectomy
Surgical treatment of ICA stenosis.

Locations

Country	Name	City	State
Hungary	Heart and Vascular Center	Budapest	Pest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive function after carotid endarterectomy	Change in MMSE score after the carotid endarterectomy compared to baseline.	six months
Primary	Change in cognitive function after carotid endarterectomy	Change in Montreal Cognitive Assessment test after the endarterectomy compared to baseline.	six months