Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals accepted CAS | Procedure: CAS and Standard medical treatment. Other:
|
| |
| Individuals accepted standard medical treatment alone. | Procedure: Standard medical treatment alone. Other:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carotid artery stenting | Procedure | 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The research population for this study consists of patients who have been diagnosed with Carotid Artery Stenosis. The inclusion criteria are: Patients aged ≥ 40 years，≥ 50% stenosis in unilateral carotid artery,sign informed consent.The exclusion criteria are: Previous history of major head trauma and any intracranial surgery,intracranial abnormalities,extrapyramidal symptoms or mental illness which may affect neuropsychological measurement,severe loss of vision, hearing, or communicative ability. The patients will be recruited from Zhejiang Provincial People's Hospital in the city of Hangzhou.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Zhang, M.D. | Contact | +8618758188313 | zhangsheng@hmc.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37236211 | Background | Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D059345 | Cerebral Small Vessel Diseases |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| drug therapy | Drug | 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. |
|
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. |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |