Carotid Artery StenosisNCT01718600
Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
An observational study of Carotid Artery Stenosis, run by Stanford University at 3 sites in United States.
Trial summary
Microembolization is commonly associated with carotid artery stenting (CAS), but our understanding of subclinical microembolization is superficial. Through collaborative effects of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to better understand the clinical significance and… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Neuropsychological testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 207 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2011to Apr 2018
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing carotid intervention
Who may be able to join
- Patient is male or female >40 yrs of age.
- Patient has occlusive extracranial carotid stenosis (≥70%)
- Patient is scheduled to undergo an endovascular intervention of a lesion in the extracranial carotid artery
- Patient agrees to voluntarily participate and signs an informed consent.
- Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
- Patient has sufficient visual and auditory acuity for cognitive testing.
Who cannot join
- Patient is unable to safely and comfortably undergo magnetic resonance imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
- Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
- Patient has prominent suicidal or homicidal ideation.
- Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
- Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
- Patient has prior closed head injury with ≥24 hours of amnesia.
- Patient is unable to understand or sign the informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Wisconsin, Madison
Madison, Wisconsin
Palo Alto Veterans Affairs
Palo Alto, California, 94304
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Microembolization is commonly associated with carotid artery stenting (CAS), but our understanding of subclinical microembolization is superficial. Through collaborative effects of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to better understand the clinical significance and long-term cognitive effects of microemboli. This proposal may change our current clinical practice by providing a better outcome measure for carotid interventions and improving outcomes of CAS procedures through risk factor stratification. Our central hypothesis is that development of subclinical microemboli is associated with decline in cognitive function following CAS and that the risk of development of microemboli themselves is associated with patient- and procedure-related factors. We hope that this prospective study will help to clarify these important issues in the era of rapidly evolving percutaneous interventions.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Neuropsychological testing
- Keywords
- carotid artery stenting, neuropsychological testing, microembolization, MRI
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Neuroimaging Correlates | Carotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this proposal, we hope to determine the risk factors and cognitive effect of microembolization following carotid revascularization procedures. Receives: Behavioral: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of microemboli in correlation with changes in neurocognitive assessment performance
Measured: 1 year following CAS procedure
Secondary outcomes (1)
Risk factor stratification for incidence of microemboli
Measured: 1 year following CAS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startJun 2011
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718600
- Sponsor's protocol ID
- R01NS070308
- Status last verified
- Aug 2022
- First submitted
- 29 Oct 2012
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhou W, Hitchner E, Gillis K, Sun L, Floyd R, Lane B, Rosen A. Prospective neurocognitive evaluation of patients undergoing carotid interventions. J Vasc Surg. 2012 Dec;56(6):1571-8. doi: 10.1016/j.jvs.2012.05.092. Epub 2012 Aug 11.
PubMed 22889720
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
- ClinicalTrials.gov ID
- NCT01718600
- Acronym / sponsor ID
- R01NS070308
- Conditions
- Carotid Artery Stenosis
- Keywords
- carotid artery stenting, neuropsychological testing, microembolization, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, Washington University School of Medicine
- Study start
- Jun 2011 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 31 Oct 2012 (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.
Microembolization is commonly associated with carotid artery stenting (CAS), but our understanding of subclinical microembolization is superficial. Through collaborative effects of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to better understand the clinical significance and long-term cognitive effects of microemboli. This proposal may change our current clinical practice by providing a better outcome measure for carotid interventions and improving outcomes of CAS procedures through risk factor stratification. Our central hypothesis is that development of subclinical microemboli is associated with decline in cognitive function following CAS and that the risk of development of microemboli themselves is associated with patient- and procedure-related factors. We hope that this prospective study will help to clarify these important issues in the era of rapidly evolving percutaneous interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroimaging Correlates | – | Behavioral: Neuropsychological testingCarotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this proposal, we hope to determine the risk factors and cognitive effect of microembolization following carotid revascularization procedures. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing carotid intervention
Key inclusion criteria (6 listed)
- Patient is male or female >40 yrs of age.
- Patient has occlusive extracranial carotid stenosis (≥70%)
- Patient is scheduled to undergo an endovascular intervention of a lesion in the extracranial carotid artery
- Patient agrees to voluntarily participate and signs an informed consent.
- Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
Key exclusion criteria (7 listed)
- Patient is unable to safely and comfortably undergo magnetic resonance imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
- Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
- Patient has prominent suicidal or homicidal ideation.
- Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
- Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
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 |
|---|---|---|
| Neuropsychological testing | Behavioural | Neuroimaging Correlates |
Primary outcome
Incidence of microemboli in correlation with changes in neurocognitive assessment performance
Time frame: 1 year following CAS procedure
1 secondary outcome
Risk factor stratification for incidence of microemboli
Time frame: 1 year following CAS procedure
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 29 Aug 2022.
- Background: PubMed 22889720Zhou W, Hitchner E, Gillis K, Sun L, Floyd R, Lane B, Rosen A. Prospective neurocognitive evaluation of patients undergoing carotid interventions. J Vasc Surg. 2012 Dec;56(6):1571-8. doi: 10.1016/j.jvs.2012.05.092. Epub 2012 Aug 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by Stanford University at 3 sites in United States.
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 6 inclusion and 7 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 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Incidence of microemboli in correlation with changes in neurocognitive assessment performance (time frame: 1 year following CAS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718600, which also lists 1 linked publication.
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 29 Aug 2022.