An observational study in Carotid Artery Stenosis and Image, sponsored by Nanjing University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-08.
Sponsored by Nanjing University of Traditional Chinese Medicine · Observational
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.
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.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
This study's planned enrollment of 100 is below the median of 176 across 159 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Nanjing University of Traditional Chinese Medicine is the lead sponsor of 17 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Carotid Artery Stenosis with cognitive normality
Device: magnetic resonance image · Diagnostic Test: Neuropsychological scale
Carotid Artery Stenosis with mild cognitive impairment
Device: magnetic resonance image · Diagnostic Test: Neuropsychological scale
Healthy controls
Device: magnetic resonance image · Diagnostic Test: Neuropsychological scale
Imaging data were collected in a strong magnetic field
Multi dimensional neuropsychological test
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.
Time frame: 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
Time frame: 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.
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
Change of serum marker concentration before and after operation
The change of serum marker concentration is evaluated by inflammatory cytokine.
Time frame: 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.
Time frame: 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
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
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
The change of executive functions is evaluated by Backward Digit Span. The minimum value is 0 , the maximum value is 4.
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
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
Time frame: before operation; 3-10 Days after operation; 1 month; 6-12months
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Nanjing University of Traditional Chinese Medicine