Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

Recruiting

• Conditions: Carotid Artery Stenosis; Cerebral Small Vessel Diseases
• Interventions: Procedure: carotid artery stenting; Drug: drug therapy

• Registration Number: NCT06031610
• Lead Sponsor: Zhejiang Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-10
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-11
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2033-12
• Study Completion: 2034-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals accepted CAS	carotid artery stenting	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.
Individuals accepted CAS	drug therapy	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.
Individuals accepted standard medical treatment alone.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China