NCT Number: NCT06031610
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Observational
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Sheng Zhang, M.D.
PRINCIPAL_INVESTIGATOR
Sheng Zhang, MD
CONTACT
+8618758188313 ext. 0571-85893472
Weitao Yu, B.S.Med
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
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.
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.
Record blood flow density (%) of OCTA.
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
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.
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.
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 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.
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,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.
Contact information is provided by the study sponsor or research team.
Zhejiang Provincial People's Hospital
Other
Acronym: RECAS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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