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

Zhejiang Provincial People's Hospital

Status: Enrolling

Conditions: Carotid Artery Stenosis; Cerebral Small Vessel Diseases

Treatments: Procedure: carotid artery stenting; Drug: drug therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06031610

ZJPPHEC2023O（290）

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Individuals accepted CAS

Description:

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.

Treatment:

Drug: drug therapy

Procedure: carotid artery stenting

Individuals accepted standard medical treatment alone.

Description:

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.

Treatment:

Drug: drug therapy