Clinical trial NCT06031610: Revascularization Effect on CSVD Burden in Carotid Artery Stenosis
Official title: Revascularization Effect on CSVD Burden in Carotid Artery Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Stenosis
Cerebral Small Vessel Diseases
Keywords: Carotid Artery Stenosis
Cerebral Small Vessel Diseases
Revascularization
Carotid artery stenting
prospective cohort
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The development of total brain small vessel disease burden in MRI
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA) score
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
measure: Mini-mental State Examination(MMSE) score
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
measure: Blood flow density
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
measure: Vascular perfusion area
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
measure: Macular fovea retinal thickness
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
measure: Retinal nerve fiber layer thickness
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
measure: Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP).
timeFrame: baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
measure: Stenosis percent
timeFrame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
measure: Number of Patients with cerebrovascular events, cardiovascular events or death
timeFrame: baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
citation: 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.