Carotid Artery StenosisNCT05848921
Evaluation of Brain Health and Surgical Efficacy in Patients With Carotid Artery Stenosis
An observational study of Carotid Artery Stenosis and Image, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to explore the relationship between the recovery of cerebrovascular morphology and cognitive function before and after surgical treatment in patients with carotid artery stenosis and their preoperative cardiac health status. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis, Image
- What is being tested?
- magnetic resonance image and Neuropsychological scale
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2025
- How long will I take part?
- 1 Year
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All of the patients of carotid artery stenosis group are in-patients and out-patients in the cardiac surgery department from the research center. The subjects of control group are recruited from community.
Who may be able to join
- Aged over 50 years old;
- Conscious and capable of completing neuropsychological scales
- Clinical detection of carotid artery stenosis requires surgical treatment;
- Compliant with carotid artery stenting or carotid endarterectomy surgical standards
- Individuals with normal cognition and mild cognitive impairment
Who cannot join
- Degree of vascular blockage in other intracranial segments ≥ 50%
- Have a history of mental illness, nervous system disease (such as stroke) or brain injury with loss of consciousness for more than five minutes;
- Neurological and psychiatric disorders unrelated to AD (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis)
- Have a history of alcohol or drug abuse
- There are contraindications for magnetic resonance imaging examination
- Those with significant organ dysfunction such as lung, liver, and kidney;
- Patients with intracranial tumors, infectious diseases, and blood system diseases;
- Participating in other clinical studies at the same time
Trial locations and contacts
1 site in 1 country.
China1 site
The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
Wenzhou, Zhejiang
Bo Yin, phD, 0086-13857773745, 76yinbo@163.com
Lijun Bai, phD, 0086-15129034948, bailijun@xjtu.edu.cn
About this study
Official title: Research on Changes of Cerebral Vascular Morphology and Cognitive Function in Patients With Carotid Artery Stenosis Before and After Surgery
The purpose of this study is to explore the relationship between the recovery of cerebrovascular morphology and cognitive function before and after surgical treatment in patients with carotid artery stenosis and their preoperative cardiac health status. And combined with preoperative cognitive status, serum markers, and cardiovascular health evaluation indicators, evaluate and predict the possibility of postoperative neurodegenerative diseases and the level of cerebrovascular health in patients.
Read the detailed description
The aim of this study is to evaluate the brain health status and surgical efficacy of patients with carotid artery stenosis. Firstly, investigate whether hemodynamic parameters such as blood flow reserve fraction at the carotid artery stenosis site are correlated with white matter hyperintensities and cerebral vascular morphological changes in elderly patients with normal cognition and mild cognitive impairment; Then, when the blood flow of carotid artery has been improved after surgery, compare the cerebrovascular health of patients before surgery and the way of cerebral vascular reconstruction; Combined with the postoperative neuropsychological cognitive test to explore the postoperative cognitive recovery of patients, and combined with the postoperative imaging data and the biomarker in the blood of patients at various stages, to explore the way of cerebral vascular reconstruction and changes in brain structure and function of different groups of patients behind cognitive changes.
- Conditions
- Carotid Artery Stenosis, Image
- Being tested
- magnetic resonance image, Neuropsychological scale
- Keywords
- Carotid Artery Stenosis, MRI Imaging
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imageDevice
Imaging data were collected in a strong magnetic field
Neuropsychological scaleDiagnostic test
Multi dimensional neuropsychological test
| Study group | Role | What they receive |
|---|---|---|
| CAS-CN | Carotid Artery Stenosis with cognitive normality Receives: Device: magnetic resonance image; Diagnostic Test: Neuropsychological scale | |
| CAS-MCI | Carotid Artery Stenosis with mild cognitive impairment Receives: Device: magnetic resonance image; Diagnostic Test: Neuropsychological scale | |
| HC | Healthy controls Receives: Device: magnetic resonance image; Diagnostic Test: Neuropsychological scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of brain volume before and after treatment
The change of brain volume (mm3) are evaluated by structural 3DT1 weighted MRI. Freesurfer software is used to get the measured value of the volume.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months]
Change of cerebrovascular morphology before and after treatment
The change of Cerebral vessel density, caliber and tortuosity, brain white matter hyperintensity lesion count
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of brain function connectivity before and after operation
The change of brain functional connectivity intensity are evaluated by rest stage functional MRI. DPABI software based on MATLAB is used to get the measured the matrix value of functional connectivity.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary outcomes (10)
Change of serum marker concentration before and after operation
The change of serum marker concentration is evaluated by inflammatory cytokine.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of plasma marker concentration before and after operation
The change of plasma marker concentration is evaluated by neurofilament light chain(NFL) protein extracted from plasma.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Brain evaluate basic cognition before operation
Basic cognition is evaluated by Mini-mental State Examination (MMSE) and Clinical Dementia Rating (CDR) . For MMSE , The minimum value is 0 , and the maximum value is 30. The higher scores mean a better outcome. For CDR , the results are represented by scores of 0,0.5,1,2,3, and the degree of cognitive impairment is classified as normal, suspicious, mild, moderate, and severe
Measured: before operation
Change of executive functions before and after operation evaluated by Trail-Making Test Part A
The change of executive functions are first evaluated by Trail-Making Test Part A test. The minimum value is 0 , and the maximum value is 30. This test has no clear maximum and minimum values. If the test completion time exceeds 79 seconds, it means the outcome is abnormal. The higher scores mean a worse outcome.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Digit Symbol Coding score
The change of executive functions are second evaluated by Digit Symbol Coding score. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 56.53 ± 20.17. The higher scores mean a better outcome.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of working memory before and after operation evaluated by Forward Digit Span
The change of working memory is first evaluated by Forward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 7.75±1.47. The higher scores mean a better outcome.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of working memory before and after operation evaluated by Backward Digit Span
The change of working memory is second evaluated by Backward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 5.36±1.91. The higher scores mean a better outcome.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of language function before and after operation evaluated by Language Fluency test
The change of language function is evaluated by Language Fluency test. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 19.43±4.81. The higher scores mean a better outcome.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Clock Drawing Test
The change of executive functions is evaluated by Backward Digit Span. The minimum value is 0 , the maximum value is 4.
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Trail-Making Test Part B
The change of executive functions are first evaluated by Trail-Making Test Part B test. The minimum value is 0 , and the maximum value is 30. This test has no clear maximum and minimum values. If the test completion time exceeds 79 seconds, it means the outcome is abnormal. The higher scores mean a worse outcome.It is a supplement to Trail-Making Test Part A, which is optional for patients who are not familiar with the English alphabetical order
Measured: before operation; 3-10 Days after operation; 1 month; 6-12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University, The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
- Responsible party
- Principal investigator, Qianyan Liu, Nanjing University of Traditional Chinese Medicine
- Investigators
- Bo Yin, phD, Principal investigator, The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848921
- Sponsor's protocol ID
- 82071993-2
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Changes of Cerebral Vascular Morphology and Cognitive Function in Patients With Carotid Artery Stenosis Before and After Surgery
- ClinicalTrials.gov ID
- NCT05848921
- Acronym / sponsor ID
- 82071993-2
- Conditions
- Carotid Artery Stenosis, Image
- Keywords
- Carotid Artery Stenosis, MRI Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University, The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 May 2023 (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.
The purpose of this study is to explore the relationship between the recovery of cerebrovascular morphology and cognitive function before and after surgical treatment in patients with carotid artery stenosis and their preoperative cardiac health status. And combined with preoperative cognitive status, serum markers, and cardiovascular health evaluation indicators, evaluate and predict the possibility of postoperative neurodegenerative diseases and the level of cerebrovascular health in patients.
Detailed description
The aim of this study is to evaluate the brain health status and surgical efficacy of patients with carotid artery stenosis. Firstly, investigate whether hemodynamic parameters such as blood flow reserve fraction at the carotid artery stenosis site are correlated with white matter hyperintensities and cerebral vascular morphological changes in elderly patients with normal cognition and mild cognitive impairment; Then, when the blood flow of carotid artery has been improved after surgery, compare the cerebrovascular health of patients before surgery and the way of cerebral vascular reconstruction; Combined with the postoperative neuropsychological cognitive test to explore the postoperative cognitive recovery of patients, and combined with the postoperative imaging data and the biomarker in the blood of patients at various stages, to explore the way of cerebral vascular reconstruction and changes in brain structure and function of different groups of patients behind cognitive changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAS-CN | – | Device: magnetic resonance image, Diagnostic Test: Neuropsychological scaleCarotid Artery Stenosis with cognitive normality |
| CAS-MCI | – | Device: magnetic resonance image, Diagnostic Test: Neuropsychological scaleCarotid Artery Stenosis with mild cognitive impairment |
| HC | – | Device: magnetic resonance image, Diagnostic Test: Neuropsychological scaleHealthy controls |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All of the patients of carotid artery stenosis group are in-patients and out-patients in the cardiac surgery department from the research center. The subjects of control group are recruited from community.
Key inclusion criteria (5 listed)
- Aged over 50 years old;
- Conscious and capable of completing neuropsychological scales
- Clinical detection of carotid artery stenosis requires surgical treatment;
- Compliant with carotid artery stenting or carotid endarterectomy surgical standards
- Individuals with normal cognition and mild cognitive impairment
Key exclusion criteria (8 listed)
- Degree of vascular blockage in other intracranial segments ≥ 50%
- Have a history of mental illness, nervous system disease (such as stroke) or brain injury with loss of consciousness for more than five minutes;
- Neurological and psychiatric disorders unrelated to AD (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis)
- Have a history of alcohol or drug abuse
- There are contraindications for magnetic resonance imaging examination
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 |
|---|---|---|
| magnetic resonance imageImaging data were collected in a strong magnetic field | Device | CAS-CN, CAS-MCI, HC |
| Neuropsychological scaleMulti dimensional neuropsychological test | Diagnostic test | CAS-CN, CAS-MCI, HC |
Primary outcome
Change of brain volume before and after treatment
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months]
The change of brain volume (mm3) are evaluated by structural 3DT1 weighted MRI. Freesurfer software is used to get the measured value of the volume.
Change of cerebrovascular morphology before and after treatment
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
The change of Cerebral vessel density, caliber and tortuosity, brain white matter hyperintensity lesion count
Change of brain function connectivity before and after operation
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
The change of brain functional connectivity intensity are evaluated by rest stage functional MRI. DPABI software based on MATLAB is used to get the measured the matrix value of functional connectivity.
10 secondary outcomes
Change of serum marker concentration before and after operation
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of plasma marker concentration before and after operation
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Brain evaluate basic cognition before operation
Time frame: before operation
Change of executive functions before and after operation evaluated by Trail-Making Test Part A
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Digit Symbol Coding score
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of working memory before and after operation evaluated by Forward Digit Span
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of working memory before and after operation evaluated by Backward Digit Span
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of language function before and after operation evaluated by Language Fluency test
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Clock Drawing Test
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Trail-Making Test Part B
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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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.
Bo Yin, phD principal investigator
The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
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 Carotid Artery Stenosis and Image, run by Nanjing University of Traditional Chinese Medicine 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 5 inclusion and 8 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 8 May 2023. 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 Bo Yin, phD (0086-13857773745, 76yinbo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of brain volume before and after treatment (time frame: before operation; 3-10 Days after operation; 1 month; 6-12months]). The study lists 3 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 8 May 2023.