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Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

Primary Purpose

Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
carotid endarterectomy
Sponsored by
Semmelweis University Heart and Vascular Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged more than 18 years, undergoing elective carotid endarterectomy

Exclusion Criteria:

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

Sites / Locations

  • Heart and Vascular CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgical treatment of carotid endarterectomy

Arm Description

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

Outcomes

Primary Outcome Measures

Change in cognitive function after carotid endarterectomy
Change in MMSE score after the carotid endarterectomy compared to baseline.
Change in cognitive function after carotid endarterectomy
Change in Montreal Cognitive Assessment test after the endarterectomy compared to baseline.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2019
Last Updated
January 7, 2022
Sponsor
Semmelweis University Heart and Vascular Center
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1. Study Identification

Unique Protocol Identification Number
NCT03907943
Brief Title
Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy
Official Title
Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University Heart and Vascular Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment of carotid endarterectomy
Arm Type
Other
Arm Description
The change in the cognitive function will be assessed in all patient undergoing carotid endarterectomy.
Intervention Type
Procedure
Intervention Name(s)
carotid endarterectomy
Intervention Description
Surgical treatment of ICA stenosis.
Primary Outcome Measure Information:
Title
Change in cognitive function after carotid endarterectomy
Description
Change in MMSE score after the carotid endarterectomy compared to baseline.
Time Frame
six months
Title
Change in cognitive function after carotid endarterectomy
Description
Change in Montreal Cognitive Assessment test after the endarterectomy compared to baseline.
Time Frame
six months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients aged more than 18 years will be enrolled.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged more than 18 years, undergoing elective carotid endarterectomy Exclusion Criteria: younger than 18 years, incapacity, urgent surgery, lack of consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia
Phone
+36203304584
Email
andi_szekely@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ágnes Sándor MD
Phone
+36208250738
Email
sandoragnesdora@gmail.com
Facility Information:
Facility Name
Heart and Vascular Center
City
Budapest
State/Province
Pest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia
Phone
+36-20-3304584
Email
andi_szekely@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ágnes Sándor MD
Phone
+36308250738
Email
sandoragnesdora@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

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