Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

ConditionsCarotid Artery Stenosis Cerebral Small Vessel Diseases

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age40-80

SponsorZhejiang Provincial People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥ 40 years.

≥ 50% stenosis in unilateral carotid artery.

Sign informed consent.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

carotid artery stenting
Procedure/Surgery
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.
drug therapy
Drug
Carotid artery stenosis requires taking antiplatelet aggregation drugs and statin lipid-lowering drugs. It can inhibit platelet aggregation, stabilize plaque, reduce vascular inflammatory factors, and prevent further development of atherosclerosis.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Individuals accepted CAS2 interventions

Group B: Individuals accepted standard medical treatment alone.1 intervention

Trial outcomes

Primary outcomes

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.

Time frame