Revascularization Effect on CSVD Burden in Carotid Artery Stenosis (RECAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Small Vessel Diseases; Carotid Artery Stenosis
• Intervention / Treatment: Procedure: carotid artery stenting

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Sheng Zhang, M.D.; Phone Number: +8618758188313; Email: zhangsheng@hmc.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Sheng Zhang, MD; Phone Number: 0571-85893472 +8618758188313; Email: zhangsheng@hmc.edu.cn
      • Principal Investigator: Sheng Zhang, M.D.
      • Sub-Investigator: Weitao Yu, B.S.Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Lancet Neurol. 2023 Sep;22(9):e10. Lancet Neurol. 2023 Sep;22(9):e10.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): May 1, 2034

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Revascularization; Carotid artery stenting; Cerebral Small Vessel Diseases; Carotid Artery Stenosis; prospective cohort
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic; Cerebral Small Vessel Diseases
• Other Study ID Numbers: ZJPPHEC2023O（290）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No