NCT03907943

Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

Status unknown NA Last updated 11 January 2022

What this trial tests

NA trial testing carotid endarterectomy in Cognitive Impairment in 150 participants. Status unknown.

Timeline

4 March 2019

Primary endpoint
31 March 2022

31 August 2022

Quick facts

Lead sponsor	Semmelweis University Heart and Vascular Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	150
Start date	4 March 2019
Primary completion	31 March 2022
Estimated completion	31 August 2022
Sites	1 location across Hungary

Drugs / interventions tested

• carotid endarterectomy

Conditions studied

• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

Semmelweis University Heart and Vascular Center

Who can join

18 and older, any sex, with Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cerebrovascular dysregulation and postoperative cognitive alterations after carotid endarterectomy.
   Sándor ÁD, Czinege Z, Szabó A, Losoncz E, et al · · 2024 · cited 4× · PMID 38877342 · DOI 10.1007/s11357-024-01237-6
2. Association of Diabetes with Greater Mid-Term Cognitive Decline After Carotid Surgery.
   Sándor ÁD, Sikos PM, Varinot G, Kallinikos F, et al · · 2025 · cited 1× · PMID 41007750 · DOI 10.3390/biomedicines13092188