NCT06031610

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
98mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jun 2023May 2034

Study Start

First participant enrolled

June 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2033

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2034

Last Updated

February 12, 2025

Status Verified

October 1, 2024

Enrollment Period

10.5 years

First QC Date

August 21, 2023

Last Update Submit

February 10, 2025

Conditions

Carotid Artery StenosisCerebral Small Vessel Diseases

Keywords

Carotid Artery StenosisCerebral Small Vessel DiseasesRevascularizationCarotid artery stentingprospective cohort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Montreal Cognitive Assessment (MoCA) score

    baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.

  • Mini-mental State Examination(MMSE) score

    baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.

  • Blood flow density

    baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.

  • Vascular perfusion area

    baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.

  • Macular fovea retinal thickness

    baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.

  • +4 more secondary outcomes

Study Arms (2)

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.

Procedure: carotid artery stentingDrug: drug therapy

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: drug therapy

Interventions

carotid artery stentingPROCEDURE

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 CAS
drug therapyDRUG

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 CASIndividuals accepted standard medical treatment alone.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients aged ≥ 40 years.
  • ≥ 50% stenosis in unilateral carotid artery.
  • Sign informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37236211BACKGROUND

Related Links

MeSH Terms

Conditions

Carotid StenosisCerebral Small Vessel Diseases

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Sheng Zhang, M.D.

CONTACT

+8618758188313zhangsheng@hmc.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 11, 2023

Study Start

June 10, 2023

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

May 1, 2034

Last Updated

February 12, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)