NCT03907943

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

March 26, 2019

Last Update Submit

January 7, 2022

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • Change in cognitive function after carotid endarterectomy

    Change in MMSE score after the carotid endarterectomy compared to baseline.

    six months

  • Change in cognitive function after carotid endarterectomy

    Change in Montreal Cognitive Assessment test after the endarterectomy compared to baseline.

    six months

Study Arms (1)

Surgical treatment of carotid endarterectomy

OTHER

The change in the cognitive function will be assessed in all patient undergoing carotid endarterectomy.

Procedure: carotid endarterectomy

Interventions

carotid endarterectomyPROCEDURE

Surgical treatment of ICA stenosis.

Surgical treatment of carotid endarterectomy

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatients aged more than 18 years will be enrolled.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged more than 18 years, undergoing elective carotid endarterectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Vascular Center

Budapest, Pest County, 1122, Hungary

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia

CONTACT

+36203304584andi_szekely@yahoo.com

Ágnes Sándor MD

CONTACT

+36208250738sandoragnesdora@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 9, 2019

Study Start

March 4, 2019

Primary Completion

March 31, 2022

Study Completion

August 31, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)