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Neurocognitive Function After Carotid Thrombendarterectomy

Primary Purpose

Carotid Stenosis, Postoperative Cognitive Dysfunction, Neurological Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
NIRS, EEG
Sponsored by
Clinical Hospital Centre Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carotid Stenosis focused on measuring CEA ACI, cognitive tests, BHI, NIRS, TCD, EEG

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with The North American Symptomatic Carotid Endarterectomy Trial (NASCET) stenosis of more than 70% symptomatic stenosis asymptomatic stenosis elective surgery patients signed informed consent initial MoCa test equal and more than 22 Exclusion Criteria: who refuse to participate previous stroke in anamnesis patient without bone window for BHI measurements comorbidities with aphasia and plegia, and the impossibility to solve cognitive tests

Sites / Locations

  • UHCZagrebRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Cerebral perfusion monitoring

Control

Arm Description

Multimodal monitoring includes cerebral oxygenation (with NIRS) and EEG (with SEDLINE). During the carotic clamp, if cerebral oxygenation decreased for more than 12 % on the operating side from the baseline value, simple interventions as, increasing arterial blood pressure, increasing arterial carbon dioxide tension or increasing oxygen inspiration concentration will be performed.

The control arm does not have any monitor of cerebral perfusion and oxygenation, during the carotic clamp only intervention is regulating arterial blood pressure values.

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment (MoCA)
A widely used screening assessment for detecting cognitive impairment. It was validated in the setting of mild cognitive impairment, and has subsequently been adopted in numerous other settings clinically. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps. The basics of this test include short-term memory, executable performance, attention, focus and more.
Trail making test (TMT) 1
Neuropsychological test that involves visual scanning and working memory. In the TMT-1 (rote memory) the subject is instructed to connect a set of 25 dots as quickly as possible (time is measured in seconds).
Trail making test (TMT) 2
TMT-2 (executive functioning) is a neuropsychological test that involves visual scanning and working memory. In this test the dots go from 1 to 13 and include letters from A to L.
Month backwards test (MBT)
It is a rapid (< 2 min) and simple to administer test of cognitive function that is widely used at the bedside. The test requests the subject to recite the months of the year in reverse order starting with December, until the subject reaches January.

Secondary Outcome Measures

Difference in brain reactivity measured by Breath holding index
Difference in breath holding index before surgery , after the surgery and after eight weeks as a surrogate of brain perfusion in both groups of patients

Full Information

First Posted
December 30, 2022
Last Updated
February 18, 2023
Sponsor
Clinical Hospital Centre Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT05739357
Brief Title
Neurocognitive Function After Carotid Thrombendarterectomy
Official Title
Perioperative Complications and Cognitive Outcome in Carotid Thrombendarterectomy With Multimodal Monitoring Cerebral Perfusion Optimisation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Centre Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Previous studies did not reach a consensus on the influence of the type of anesthesiologic procedure and monitoring, during carotid thrombendarterectomy, on perioperative complications and cognitive outcomes. The aim of this study is the optimization of brain perfusion during the vascular carotid clamp using multimodal monitoring. We assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of subclinical cognitive deficits.
Detailed Description
ABSTRACT: AIM OF THE STUDY: Effect of perioperative multimodal monitoring with transcranial doppler (TCD), near-infrared spectroscopy (NIRS), and Electroencephalography (EEG) in patients for carotid thrombendarterectomy (CEA) on perioperative complications and cognitive functions. PATIENTS AND METHODS: The prospective study will analyze 80 consecutive patients with an asymptomatic and symptomatic (transitory ischemic attack, TIA, in anamnesis) stenosis of the internal carotid artery in which CEA is indicated in general anesthesia. Cognitive tests will be analyzed for all patients preoperatively, first and eighth day postoperatively, and after 8 weeks. Breath-holding index (BHI) will be measured preoperatively and postoperatively. The first group of patients (n = 40) will have expanded intraoperative monitoring involving TCD, NIRS, and EEG, and the control group (n = 40) will have only standard anesthetic monitoring. EXPECTED CONTRIBUTION OF THE STUDY: Previous studies did not agree on the influence of the type of anesthesiologic procedure and monitoring of perioperative complications and cognitive outcomes. We assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of the effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis, Postoperative Cognitive Dysfunction, Neurological Impairment
Keywords
CEA ACI, cognitive tests, BHI, NIRS, TCD, EEG

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerebral perfusion monitoring
Arm Type
Active Comparator
Arm Description
Multimodal monitoring includes cerebral oxygenation (with NIRS) and EEG (with SEDLINE). During the carotic clamp, if cerebral oxygenation decreased for more than 12 % on the operating side from the baseline value, simple interventions as, increasing arterial blood pressure, increasing arterial carbon dioxide tension or increasing oxygen inspiration concentration will be performed.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm does not have any monitor of cerebral perfusion and oxygenation, during the carotic clamp only intervention is regulating arterial blood pressure values.
Intervention Type
Device
Intervention Name(s)
NIRS, EEG
Other Intervention Name(s)
cerebral oximetry
Intervention Description
During the carotic clamp, if cerebral oxygenation decreased for more than 12 % on the operating side from the baseline value, simple interventions as, increasing arterial blood pressure, increasing arterial carbon dioxide tension or increasing oxygen inspiration concentration will be performed.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
A widely used screening assessment for detecting cognitive impairment. It was validated in the setting of mild cognitive impairment, and has subsequently been adopted in numerous other settings clinically. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps. The basics of this test include short-term memory, executable performance, attention, focus and more.
Time Frame
Change in measurements (result is in numbers) done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
Title
Trail making test (TMT) 1
Description
Neuropsychological test that involves visual scanning and working memory. In the TMT-1 (rote memory) the subject is instructed to connect a set of 25 dots as quickly as possible (time is measured in seconds).
Time Frame
Changes in measurements (results are in seconds) done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
Title
Trail making test (TMT) 2
Description
TMT-2 (executive functioning) is a neuropsychological test that involves visual scanning and working memory. In this test the dots go from 1 to 13 and include letters from A to L.
Time Frame
Changes in measurements done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
Title
Month backwards test (MBT)
Description
It is a rapid (< 2 min) and simple to administer test of cognitive function that is widely used at the bedside. The test requests the subject to recite the months of the year in reverse order starting with December, until the subject reaches January.
Time Frame
changes in measurements done at four time points (before surgery, day after the surgery, on 7th day and after 8 weeks
Secondary Outcome Measure Information:
Title
Difference in brain reactivity measured by Breath holding index
Description
Difference in breath holding index before surgery , after the surgery and after eight weeks as a surrogate of brain perfusion in both groups of patients
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with The North American Symptomatic Carotid Endarterectomy Trial (NASCET) stenosis of more than 70% symptomatic stenosis asymptomatic stenosis elective surgery patients signed informed consent initial MoCa test equal and more than 22 Exclusion Criteria: who refuse to participate previous stroke in anamnesis patient without bone window for BHI measurements comorbidities with aphasia and plegia, and the impossibility to solve cognitive tests
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Tomic Mahecic
Phone
+38598457189
Email
tinatomic72@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Tomic Mahecic
Organizational Affiliation
UHC Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHCZagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Tomić Mahečić
Phone
38598457189
Email
tinatomic72@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurocognitive Function After Carotid Thrombendarterectomy

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