Carotid Artery Stenosis, Cerebral Small Vessel Diseases
Conditions
Keywords
Carotid Artery Stenosis, Cerebral Small Vessel Diseases, Revascularization, Carotid artery stenting, prospective cohort
Brief summary
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.
Interventions
PROCEDUREcarotid artery stenting
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.
DRUGdrug therapy
Carotid artery stenosis requires taking antiplatelet aggregation drugs and statin lipid-lowering drugs. It can inhibit platelet aggregation, stabilize plaque, reduce vascular inflammatory factors, and prevent further development of atherosclerosis.
Sponsors
Zhejiang Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥ 40 years. 2. ≥ 50% stenosis in unilateral carotid artery. 3. Sign informed consent.
Exclusion criteria
1. Previous history of major head trauma and any intracranial surgery 2. Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions 3. Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement. 4. Severe loss of vision, hearing, or communicative ability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The development of total brain small vessel disease burden in MRI | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini-mental State Examination(MMSE) score | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | To assess changes in cognitive function of patients. |
| Blood flow density | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | Record blood flow density (%) of OCTA. |
| Vascular perfusion area | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | Record vascular perfusion area (mm\^2) of OCTA. |
| Macular fovea retinal thickness | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | Record macular fovea retinal thickness (μm) of OCTA. |
| Montreal Cognitive Assessment (MoCA) score | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | To assess changes in cognitive function of patients. |
| Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP). | baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | Change of the volume of delay time\>3s in follow-up minus the volume at baseline. |
| Stenosis percent | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 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. |
| Number of Patients with cerebrovascular events, cardiovascular events or death | baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years. | 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. |
| Retinal nerve fiber layer thickness | baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years. | Record retinal nerve fiber layer thickness (μm) of OCTA. |
Countries
China
Contacts
Primary ContactSheng Zhang, M.D.
Outcome results
None listed