Carotid StenosisNCT01337128
Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
A study testing Carotid endarterectomy (CEA), Carotid stenting (CAS) and Neurocognitive functions in people with Carotid Stenosis, run by University Ghent at 1 site in Belgium.
Trial summary
In this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Carotid endarterectomy (CEA), Carotid stenting (CAS) and Neurocognitive functions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2011to Sep 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with carotid stenosis.
Who cannot join
- Significant medical conditions which affect neurocognitive functions (e.g. cancer, epilepsy)
- Older than 80 years
- A history of psychiatric or neurological illness
- Severe alcohol of drug abuse
- Coronary artery bypass graft (CABG) less than a year ago.
Trial locations and contacts
1 site in 1 country.
About this study
In this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will also be gathered. The mix of these data will allow us to answer several questions regarding the absence or presence of preoperative impairments, postoperative changes in cognitive performance and possible differences between CEA and CAS regarding postoperative neuropsychological functions. The use of a matched control group and implementation of a long term follow-up will contribute to the uniqueness of this study. It will meet several flaws of previous studies and will complete the ongoing randomized studies comparing CEA and CAS that are lacking neuropsychological data.
- Conditions
- Carotid Stenosis
- Being tested
- Carotid endarterectomy (CEA), Carotid stenting (CAS), Neurocognitive functions, Levels of biomarkers, Detection of peri-operative embolization
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomy (CEA)Procedure or surgery
Carotid endarterectomy (CEA) will be performed on the patients
Carotid stenting (CAS)Procedure or surgery
Carotid Stenting (CAS) will be performed on these patients.
Neurocognitive functionsProcedure or surgery
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Levels of biomarkersProcedure or surgery
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Detection of peri-operative embolizationProcedure or surgery
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Validation resultsProcedure or surgery
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy (CEA) | Experimental | Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy. Receives: Procedure: Carotid endarterectomy (CEA); Procedure: Neurocognitive functions; Procedure: Levels of biomarkers; Procedure: Detection of peri-operative embolization; Procedure: Validation results |
| Carotid Stenting (CAS) | Experimental | Patients with carotid stenosis who are randomly assigned to a carotid stenting. Receives: Procedure: Carotid stenting (CAS); Procedure: Neurocognitive functions; Procedure: Levels of biomarkers; Procedure: Detection of peri-operative embolization; Procedure: Validation results |
| matched control group | No intervention | Matched control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative neuropsychological state
Pen and paper tests will be performed.
Measured: pre-operative
Post-operative neuropsychological state (3 weeks)
Pen and paper tests will be performed.
Measured: after 3 weeks
Post-operative neuropsychological state (6 months)
Pen and paper tests will be performed.
Measured: after 6 months
Post-operative neuropsychological state (1 year)
Pen and paper tests will be performed.
Measured: after 1 year
Secondary outcomes (10)
Levels of biomarkers pre-operatively
Levels of biomarkers (protein S100B) will also be examined pre-operatively.
Measured: pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
Determination of cardiovascular risks pre-operatively
questionnaires
Measured: pre-operatively
Determination of cardiovascular risks after 3 weeks
questionnaires
Measured: after 3 weeks
Determination of cardiovascular risks after 6 months
questionnaires
Measured: after 6 months
Determination of cardiovascular risks after 1 year
questionnaires
Measured: after 1 year
Clinical neurological examination after 3 weeks
Measured: after 3 weeks
Clinical neurological examination after 6 months
Measured: after 6 months
Clinical neurological examination after 1 year
Measured: after 1 year
Peri-operative embolization
A transcranial doppler ultrasonography will be performed.
Measured: Peri-operative
Validation results
MRI-scan will be used.
Measured: pre- and post-operative after 48 hours and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Frank Vermassen, Ph.D., M.D., Principal investigator, University Hospital, GhentGuy Vingerhoets, Ph.D., Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337128
- Sponsor's protocol ID
- 2010/819
- Status last verified
- Nov 2021
- First submitted
- 15 Apr 2011
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
- ClinicalTrials.gov ID
- NCT01337128
- Acronym / sponsor ID
- 2010/819
- Conditions
- Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- Apr 2011 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Apr 2011 (estimated)
- 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.
In this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will also be gathered. The mix of these data will allow us to answer several questions regarding the absence or presence of preoperative impairments, postoperative changes in cognitive performance and possible differences between CEA and CAS regarding postoperative neuropsychological functions. The use of a matched control group and implementation of a long term follow-up will contribute to the uniqueness of this study. It will meet several flaws of previous studies and will complete the ongoing randomized studies comparing CEA and CAS that are lacking neuropsychological data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy (CEA) | Experimental | Procedure: Carotid endarterectomy (CEA), Procedure: Neurocognitive functions, Procedure: Levels of biomarkers, Procedure: Detection of peri-operative embolization, Procedure: Validation resultsPatients with carotid stenosis who are randomly assigned to a carotid endarterectomy. |
| Carotid Stenting (CAS) | Experimental | Procedure: Carotid stenting (CAS), Procedure: Neurocognitive functions, Procedure: Levels of biomarkers, Procedure: Detection of peri-operative embolization, Procedure: Validation resultsPatients with carotid stenosis who are randomly assigned to a carotid stenting. |
| matched control group | No intervention | –Matched control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with carotid stenosis.
Key exclusion criteria (5 listed)
- Significant medical conditions which affect neurocognitive functions (e.g. cancer, epilepsy)
- Older than 80 years
- A history of psychiatric or neurological illness
- Severe alcohol of drug abuse
- Coronary artery bypass graft (CABG) less than a year ago.
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 endarterectomy (CEA)Carotid endarterectomy (CEA) will be performed on the patients | Procedure or surgery | Carotid endarterectomy (CEA) |
| Carotid stenting (CAS)Carotid Stenting (CAS) will be performed on these patients. | Procedure or surgery | Carotid Stenting (CAS) |
| Neurocognitive functionsNeurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year. | Procedure or surgery | Carotid Stenting (CAS), Carotid endarterectomy (CEA) |
| Levels of biomarkersLevels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours. | Procedure or surgery | Carotid Stenting (CAS), Carotid endarterectomy (CEA) |
| Detection of peri-operative embolizationA Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization. | Procedure or surgery | Carotid Stenting (CAS), Carotid endarterectomy (CEA) |
| Validation resultsOn a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks. | Procedure or surgery | Carotid Stenting (CAS), Carotid endarterectomy (CEA) |
Primary outcome
Pre-operative neuropsychological state
Time frame: pre-operative
Pen and paper tests will be performed.
Post-operative neuropsychological state (3 weeks)
Time frame: after 3 weeks
Pen and paper tests will be performed.
Post-operative neuropsychological state (6 months)
Time frame: after 6 months
Pen and paper tests will be performed.
Post-operative neuropsychological state (1 year)
Time frame: after 1 year
Pen and paper tests will be performed.
10 secondary outcomes
Levels of biomarkers pre-operatively
Time frame: pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
Determination of cardiovascular risks pre-operatively
Time frame: pre-operatively
Determination of cardiovascular risks after 3 weeks
Time frame: after 3 weeks
Determination of cardiovascular risks after 6 months
Time frame: after 6 months
Determination of cardiovascular risks after 1 year
Time frame: after 1 year
Clinical neurological examination after 3 weeks
Time frame: after 3 weeks
Clinical neurological examination after 6 months
Time frame: after 6 months
Clinical neurological examination after 1 year
Time frame: after 1 year
Peri-operative embolization
Time frame: Peri-operative
Validation results
Time frame: pre- and post-operative after 48 hours and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
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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.
Frank Vermassen, Ph.D., M.D. principal investigator
University Hospital, Ghent
Guy Vingerhoets, Ph.D., Professor principal investigator
University Ghent
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 (CEA), Carotid stenting (CAS) and Neurocognitive functions in people with Carotid Stenosis, run by University Ghent at 1 site in Belgium.
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 5 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: finished, as of the sponsor's last update on 1 Dec 2021. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative neuropsychological state (time frame: pre-operative). The study lists 4 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 1 Dec 2021.