RECAS: Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

Sponsor

Zhejiang Provincial People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06031610

Collaborator

(none)

1,000

Enrollment

Location

130.7

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis Cerebral Small Vessel Diseases	Procedure: carotid artery stenting

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

Actual Study Start Date :

Jun 10, 2023

Anticipated Primary Completion Date :

Dec 1, 2033

Anticipated Study Completion Date :

May 1, 2034

Arms and Interventions

Arm	Intervention/Treatment
Individuals accepted CAS Procedure: CAS and Standard medical treatment. Other: Neuropsychological testing. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI. Optical coherence tomography angiography.	Procedure: carotid 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.
Individuals accepted standard medical treatment alone. Procedure: Standard medical treatment alone. Other: Neuropsychological testing. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI. Optical coherence tomography angiography.

Arm

Intervention/Treatment

Individuals accepted CAS

Procedure: CAS and Standard medical treatment. Other: Neuropsychological testing. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI. Optical coherence tomography angiography.

Procedure: carotid 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.

Individuals accepted standard medical treatment alone.

Procedure: Standard medical treatment alone. Other: Neuropsychological testing. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI. Optical coherence tomography angiography.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged ≥ 40 years.
≥ 50% stenosis in unilateral carotid artery.
Sign informed consent.

Exclusion Criteria:

Previous history of major head trauma and any intracranial surgery
Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions
Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.
Severe loss of vision, hearing, or communicative ability.