MRI, FunctionalNCT05292729
Cognitive Function and Brain Connectivity in CAS Patients:a Rs-fMRI Study
An observational study of MRI, Functional and Carotid Artery Stenosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a prospective study aimed to explore the changes of cognitive function after surgery for CAS and the correlation with brain connectivity, in order to look for the clinical biomarkers to predict the carotid stent implantation for patients which can effect the cognition Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MRI, Functional, Carotid Artery Stenosis
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Jul 2022
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive enrolled patients with carotid artery stenosis who undergoing carotid artery stenting
Who may be able to join
- age between 55 years and 80 years
- unilateral internal carotid artery stenotic degree ≥ 70%
- right-hand-dominant
- free of stroke, TIA, dementia, and depression
- modified Rankin Scale: 0 or 1
- education ≥6 years
- obtained written informed consent.
Who cannot join
- contralateral internal carotid artery stenosis ≥ 50%
- posterior circulation diseases
- MMSE < 26, which is a cut-off value for mild cognitive impairment
- severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure and history of stroke)
- any contraindications for MRI scan (e.g., metal implants)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Zhejiang university
Hangzhou, Zhejiang, 310016
仁杰 计, 13738101002
Benyan Luo, PhD
About this study
Official title: Cognitive Function and Brain Connectivity in Carotid Artery Stenting Patients:a Rs-fMRI Study
This is a prospective study aimed to explore the changes of cognitive function after surgery for CAS and the correlation with brain connectivity, in order to look for the clinical biomarkers to predict the carotid stent implantation for patients which can effect the cognition
Read the detailed description
Carotid artery stenting (CAS) can significantly decrease the incidence of ischemic stroke in patients with severe carotid artery stenosis has been confirmed in large randomized controlled studies (1, 2).Previous studies showed carotid artery stenosis is closely related to cognitive dysfunction, including asymptomatic carotid artery stenosis(≥70%).Cognitive impairment is one of the most serious problem facing the elderly. The impact on cognitive function in patients with CAS has been discussed by many researchers, however the effect still remained conflicting.
In past few years, several imaging techniques, such as resting-state functional MRI (R-fMRI), had been increasingly used to study cognitive impairment in humans. In this study, we evaluated the cognition performance in severe carotid artery stenosis patients undergoing CAS and explored the mechanisms underlying the cognition changes by the Rs-fMRI.
Inclusion criteria:
- age between 55 years and 80 years
- unilateral internal carotid artery stenotic degree ≥ 70%
- right-hand-dominant
- free of dementia, and depression
- modified Rankin Scale: 0 or 1
- education ≥6 years
- obtained written informed consent.
Exclusion criteria:
- contralateral internal carotid artery stenosis ≥ 50%
- posterior circulation diseases
- MMSE < 26, which is a cut-off value for mild cognitive impairment
- severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure)
- any contraindications for MRI scan (e.g., metal implants)
- Non atherosclerotic stenosis, such as dissection, vasculitis.
- Conditions
- MRI, Functional, Carotid Artery Stenosis
- Keywords
- resting state, MRI, carotid artery stenting, cognition
- Medical subject headings
- Carotid Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment, MOCA
use MOCA to assess the cognition before CAS
Measured: before CAS(within 1 week)
Mini-mental State Examination，MMSE
use MMSE to assess the cognition before CAS
Measured: before CAS(within 1 week)
Montreal Cognitive Assessment, MOCA
use MOCA to assess the cognition after CAS
Measured: 3 months after CAS
Mini-mental State Examination，MMSE
use MMSE to assess the cognition after CAS
Measured: 3 months after CAS
Secondary outcomes (6)
Digit Symbol Test
use to assess the cognition before CAS
Measured: before CAS(within 1 week)
Digit Symbol Test
use to assess the cognition after CAS
Measured: 3 months after CAS
Trail Making Test A/B
use to assess the cognition before CAS
Measured: before CAS(within 1 week)
Trail Making Test A/B
use to assess the cognition after CAS
Measured: 3 months after CAS
digital span test
use to assess the cognition before CAS
Measured: before CAS(within 1 week)
digital span test
use to assess the cognition after CAS
Measured: 3 months after CAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
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 MRI, FunctionalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benyan Luo, PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292729
- Sponsor's protocol ID
- 3.0T rs-fMRI
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji R, Zhang S, Chen H, Deng C, Xu Z, Zhang J, Luo B. Impact of Endovascular Revascularization on Functional Connectivity and Cognition in Symptomatic Chronic Internal Carotid Artery Occlusion Patients: A Preliminary Exploratory Study. J Integr Neurosci. 2025 Apr 24;24(4):36330. doi: 10.31083/JIN36330.
PubMed 40302264
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function and Brain Connectivity in Carotid Artery Stenting Patients:a Rs-fMRI Study
- ClinicalTrials.gov ID
- NCT05292729
- Acronym / sponsor ID
- 3.0T rs-fMRI
- Conditions
- MRI, Functional, Carotid Artery Stenosis
- Keywords
- resting state, MRI, carotid artery stenting, cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 23 Mar 2022 (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.
This is a prospective study aimed to explore the changes of cognitive function after surgery for CAS and the correlation with brain connectivity, in order to look for the clinical biomarkers to predict the carotid stent implantation for patients which can effect the cognition
Detailed description
Carotid artery stenting (CAS) can significantly decrease the incidence of ischemic stroke in patients with severe carotid artery stenosis has been confirmed in large randomized controlled studies (1, 2).Previous studies showed carotid artery stenosis is closely related to cognitive dysfunction, including asymptomatic carotid artery stenosis(≥70%).Cognitive impairment is one of the most serious problem facing the elderly. The impact on cognitive function in patients with CAS has been discussed by many researchers, however the effect still remained conflicting.
In past few years, several imaging techniques, such as resting-state functional MRI (R-fMRI), had been increasingly used to study cognitive impairment in humans. In this study, we evaluated the cognition performance in severe carotid artery stenosis patients undergoing CAS and explored the mechanisms underlying the cognition changes by the Rs-fMRI.
Inclusion criteria:
- age between 55 years and 80 years
- unilateral internal carotid artery stenotic degree ≥ 70%
- right-hand-dominant
- free of dementia, and depression
- modified Rankin Scale: 0 or 1
- education ≥6 years
- obtained written informed consent.
Exclusion criteria:
- contralateral internal carotid artery stenosis ≥ 50%
- posterior circulation diseases
- MMSE < 26, which is a cut-off value for mild cognitive impairment
- severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure)
- any contraindications for MRI scan (e.g., metal implants)
- Non atherosclerotic stenosis, such as dissection, vasculitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive enrolled patients with carotid artery stenosis who undergoing carotid artery stenting
Key inclusion criteria (7 listed)
- age between 55 years and 80 years
- unilateral internal carotid artery stenotic degree ≥ 70%
- right-hand-dominant
- free of stroke, TIA, dementia, and depression
- modified Rankin Scale: 0 or 1
Key exclusion criteria (5 listed)
- contralateral internal carotid artery stenosis ≥ 50%
- posterior circulation diseases
- MMSE < 26, which is a cut-off value for mild cognitive impairment
- severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure and history of stroke)
- any contraindications for MRI scan (e.g., metal implants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montreal Cognitive Assessment, MOCA
Time frame: before CAS(within 1 week)
use MOCA to assess the cognition before CAS
Mini-mental State Examination，MMSE
Time frame: before CAS(within 1 week)
use MMSE to assess the cognition before CAS
Montreal Cognitive Assessment, MOCA
Time frame: 3 months after CAS
use MOCA to assess the cognition after CAS
Mini-mental State Examination，MMSE
Time frame: 3 months after CAS
use MMSE to assess the cognition after CAS
6 secondary outcomes
Digit Symbol Test
Time frame: before CAS(within 1 week)
Digit Symbol Test
Time frame: 3 months after CAS
Trail Making Test A/B
Time frame: before CAS(within 1 week)
Trail Making Test A/B
Time frame: 3 months after CAS
digital span test
Time frame: before CAS(within 1 week)
digital span test
Time frame: 3 months after CAS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 40302264Ji R, Zhang S, Chen H, Deng C, Xu Z, Zhang J, Luo B. Impact of Endovascular Revascularization on Functional Connectivity and Cognition in Symptomatic Chronic Internal Carotid Artery Occlusion Patients: A Preliminary Exploratory Study. J Integr Neurosci. 2025 Apr 24;24(4):36330. doi: 10.31083/JIN36330.
- 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.
Benyan Luo, PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MRI, Functional and Carotid Artery Stenosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 23 Mar 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 China. 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 Renjie Ji, Master (+86 13738101002, zjujirenjie@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment, MOCA (time frame: before CAS(within 1 week)). 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?
On the ClinicalTrials.gov record for NCT05292729, 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 23 Mar 2022.