Cognitive ImpairmentNCT03907943
Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy
A study testing carotid endarterectomy in people with Cognitive Impairment, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- carotid endarterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 4 Mar 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged more than 18 years, undergoing elective carotid endarterectomy
Who cannot join
- younger than 18 years, incapacity, urgent surgery, lack of consent
Trial locations and contacts
1 site in 1 country.
Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia contact
Hungary1 site, 1 recruiting
- Recruiting
Heart and Vascular Center
Budapest, Pest County, 1122
Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia, +36-20-3304584, andi_szekely@yahoo.com
Ágnes Sándor MD, +36308250738, sandoragnesdora@gmail.com
About this study
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.
Read more
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.
- Conditions
- Cognitive Impairment
- Being tested
- carotid endarterectomy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid endarterectomyProcedure or surgery
Surgical treatment of ICA stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment of carotid endarterectomy | Other | The change in the cognitive function will be assessed in all patient undergoing carotid endarterectomy. Receives: Procedure: carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function after carotid endarterectomy
Change in MMSE score after the carotid endarterectomy compared to baseline.
Measured: six months
Change in cognitive function after carotid endarterectomy
Change in Montreal Cognitive Assessment test after the endarterectomy compared to baseline.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start4 Mar 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907943
- Sponsor's protocol ID
- 17/2019
- Status last verified
- Jan 2022
- First submitted
- 26 Mar 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT03907943
- Acronym / sponsor ID
- 17/2019
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment of carotid endarterectomy | Other | Procedure: carotid endarterectomyThe change in the cognitive function will be assessed in all patient undergoing carotid endarterectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged more than 18 years, undergoing elective carotid endarterectomy
Key exclusion criteria (1 listed)
- younger than 18 years, incapacity, urgent surgery, lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carotid endarterectomySurgical treatment of ICA stenosis. | Procedure or surgery | Surgical treatment of carotid endarterectomy |
Primary outcome
Change in cognitive function after carotid endarterectomy
Time frame: six months
Change in MMSE score after the carotid endarterectomy compared to baseline.
Change in cognitive function after carotid endarterectomy
Time frame: six months
Change in Montreal Cognitive Assessment test after the endarterectomy compared to baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carotid endarterectomy in people with Cognitive Impairment, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia (+36203304584, andi_szekely@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function after carotid endarterectomy (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.