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Идёт набор NCT06031610

Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

— Наблюдательное Carotid Artery Stenosis Cerebral Small Vessel Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: carotid artery stenting, drug therapy.
Кому может быть актуально
Состояния в реестре: Carotid Artery Stenosis, Cerebral Small Vessel Diseases. Базовые параметры: 40 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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.

Вмешательства

  • Процедура 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.
  • Препарат 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.

Первичные конечные точки

  • The development of total brain small vessel disease burden in MRI [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
Вторичные конечные точки (9)
  • Montreal Cognitive Assessment (MoCA) score [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
  • Mini-mental State Examination(MMSE) score [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
  • Blood flow density [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
  • Vascular perfusion area [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
  • Macular fovea retinal thickness [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
  • Retinal nerve fiber layer thickness [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
  • Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP). [Срок оценки: baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
  • Stenosis percent [Срок оценки: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.]
  • Number of Patients with cerebrovascular events, cardiovascular events or death [Срок оценки: baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Zhejiang Provincial People's Hospital — Ханчжоу

Публикации

  • 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, Rudilo PMID 37236211

Идентификаторы

NCT: NCT06031610 · ZJPPHEC2023O（290）

Первоисточники (государственные реестры)

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