Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

NCT ID: NCT06031610

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2034-05-31

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.

Conditions

Carotid Artery Stenosis; Cerebral Small Vessel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals accepted CAS

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.

carotid artery stenting

Intervention Type: PROCEDURE

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

Intervention Type: 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.

Individuals accepted standard medical treatment alone.

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.

drug therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

drug therapy

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sheng Zhang, M.D.

Role: CONTACT

zhangsheng@hmc.edu.cn

+8618758188313

Facility Contacts

Sheng Zhang, MD

Role: primary

zhangsheng@hmc.edu.cn

+8618758188313 ext. 0571-85893472

References

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.

Reference Type: BACKGROUND

PMID: 37236211 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/37236211/

Related Info

Other Identifiers

ZJPPHEC2023O（290）

Identifier Type: -

Identifier Source: org_study_id