Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

Study Overview
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Brief Summary
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RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.

Official Title
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Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

Conditions
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Carotid Artery Stenosis, Cerebral Small Vessel Diseases

Intervention / Treatment
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* Procedure: carotid artery stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 40 years. ≥ 50% stenosis in unilateral carotid artery. Sign informed consent. Exclusion Criteria: Previous history of major head trauma and any intracranial surgery Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement. Severe loss of vision, hearing, or communicative ability.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals accepted CAS<br>Procedure: CAS and Standard medical treatment. Other: Neuropsychological testing. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI. Optical coherence tomography angiography. | Procedure: carotid artery stenting<br>* Patients were monitored for at least 24 h after surgery, with control for hyperperfusion syndrome, dual antiplatelet therapy was continued for 4-6 weeks, and the postoperative patients have the final residual stenosis of less than 30%, thrombolysis in Myocardial Infarction (TIMI) grade 3, and no dissection or thrombosis. Any surgery-related complications were recorded.<br>|
| Individuals accepted standard medical treatment alone.<br>Procedure: Standard medical treatment alone. Other: Neuropsychological testing. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI. Optical coherence tomography angiography. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of total brain small vessel disease burden in MRI | Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) score | To assess changes in cognitive function of patients. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 
| Mini-mental State Examination(MMSE) score | To assess changes in cognitive function of patients. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 
| Blood flow density | Record blood flow density (%) of OCTA. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 
| Vascular perfusion area | Record vascular perfusion area (mm^2) of OCTA. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 
| Macular fovea retinal thickness | Record macular fovea retinal thickness (μm) of OCTA. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 
| Retinal nerve fiber layer thickness | Record retinal nerve fiber layer thickness (μm) of OCTA. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 
| Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP). | Change of the volume of delay time>3s in follow-up minus the volume at baseline. | baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 
| Stenosis percent | Restenosis can be identified by CTA/DSA evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention. | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 
| Number of Patients with cerebrovascular events, cardiovascular events or death | Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and cerebral hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death. | baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid Artery Stenosis, Cerebral Small Vessel Diseases, Revascularization, Carotid artery stenting, prospective cohort