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NCT Number: NCT06031610

Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

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.

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Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Carotid Artery Stenting

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

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.

Primary outcomes

  1. The development of total brain small vessel disease burden in MRI

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

    Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.

Secondary outcomes

  1. Montreal Cognitive Assessment (MoCA) score

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

    To assess changes in cognitive function of patients.

  2. Mini-mental State Examination(MMSE) score

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

    To assess changes in cognitive function of patients.

  3. Blood flow density

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

    Record blood flow density (%) of OCTA.

  4. Vascular perfusion area

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

    Record vascular perfusion area (mm^2) of OCTA.

  5. Macular fovea retinal thickness

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

    Record macular fovea retinal thickness (μm) of OCTA.

  6. Retinal nerve fiber layer thickness

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

    Record retinal nerve fiber layer thickness (μm) of OCTA.

  7. Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP).

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

    Change of the volume of delay time>3s in follow-up minus the volume at baseline.

  8. Stenosis percent

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

    Restenosis can be identified by CTA/DSA evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention.

  9. Number of Patients with cerebrovascular events, cardiovascular events or death

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

    Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and cerebral hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Acronym: RECAS

Important dates

Study start
2023
Primary completion
2033
Study completion
2034
First posted
Sep 11, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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