Меню
Идёт набор NCT06336174

Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study

— Наблюдательное Intracranial Atherosclerosis Cognitive Impairment Cerebrovascular Event

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: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin, Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin.
Кому может быть актуально
Состояния в реестре: Intracranial Atherosclerosis, Cognitive Impairment, Cerebrovascular Event. Базовые параметры: 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Atherosclerotic Stenosis Patients: A Multicenter Cohort Study

Обзор

The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.

Подробное описание

All participants underwent a medical evaluation that included routine laboratory studies before and after 3-month and 1-year follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 3-month and 1-year follow-up.

About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Chinese Auditory Verbal Learning Test (CAVLT), Digital Span Test (DST), , Stroop color test (Stroop test), Color trail test (CTT), Clock Drawing Test (CDT), Verbal Fluency Test (VFT), etc., at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD). Furthermore, the memory and the occurrence of cerebrovascular events as the primary outcome measure, this study focused on the multidimensional cognitive function and cerebrovascular events of patients with symptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.

After 3-month and 1-year follow-up, the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.

Вмешательства

  • Препарат Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
    All patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
  • Процедура Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
    All patients underwent endovascular therapy and received standard medical management after surgery, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.

Первичные конечные точки

  • The changes in Memory [Срок оценки: baseline, 3-month and 1-year follow-up]
  • Occurrence of ischemic cerebrovascular events [Срок оценки: baseline, 3-month and 1-year follow-up]
Вторичные конечные точки (12)
  • MoCA (Montreal Cognitive Assessment) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • MMSE (Mini Mental State Examination) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • DST (Digital Span Test; Forward and Backward) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • The Stroop Color Test [Срок оценки: baseline, 3-month and 1-year follow-up]
  • CTT (Color Trail Test) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • CDT (Clock drawing test) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • VFT (Verbal Fluency Test) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • HAMD (Hamilton Depression Scale) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • HAMA (Hamilton Anxiety Scale) [Срок оценки: baseline, 3-month and 1-year follow-up]
  • MRI measure- resting state MRI images [Срок оценки: baseline, 3-month and 1-year follow-up]
  • MRI measures-structural phase MRI images [Срок оценки: baseline, 3-month and 1-year follow-up]
  • MRI measures-3D pCASL images [Срок оценки: baseline, 3-month and 1-year follow-up]

Критерии участия

Критерии включения

  • Age between 18 and 80 years
  • Severe stenosis (≥70%-99%) of atherosclerotic internal carotid artery (C6 segment, C7 segment) or middle cerebral artery (M1 segment) confirmed by digital subtraction angiography (DSA) or at least two of the following non-invasive examinations: magnetic resonance angiography (MRA), computed tomography angiography (CTA), or transcranial Doppler (TCD)
  • Transient ischemic attack (TIA) or minor stroke (National Institute of Health Stroke Scale \[NIHSS\] score ≤ 4 points)
  • Right-handed and able to cooperate in neuropsychological tests
  • At least 14 days post-onset of cerebral infarction or TIA
  • Signed informed consent

Критерии исключения

  • Other diseases that affect cognitive function, such as cerebral hemorrhage, •Parkinson's disease, neurosyphilis, dementia, tumors, etc.
  • Right upper limb hemiplegia, aphasia, visual field defects, or visual impairments
  • More than 50% stenosis of the extracranial internal carotid artery, the vertebral artery, or the basilar artery
  • Vasculitis, moyamoya disease, and cardiogenic stroke
  • Previous history of head and neck stent implantation, carotid endarterectomy, aneurysm embolization, or other intracranial surgeries

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
  • Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT06336174 · Anhui-SIA-cohort

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗