An observational study in Carotid Artery Stenosis and Cerebral Small Vessel Diseases, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Zhejiang Provincial People's Hospital · Observational
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.
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 173 across 144 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Procedure: CAS and Standard medical treatment. Other: 1. Neuropsychological testing. 2. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. 3. Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI. 4. Optical coherence tomography angiography.
Procedure: carotid artery stenting · Drug: drug therapy
Procedure: Standard medical treatment alone. Other: 1. Neuropsychological testing. 2. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. 3. Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI. 4. Optical coherence tomography angiography.
Drug: drug therapy
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.
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.
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.
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Montreal Cognitive Assessment (MoCA) score
To assess changes in cognitive function of patients.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhejiang Provincial People's Hospital