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Набор скоро начнётся NCT07726654

The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

— Наблюдательное Cerebral Small Vessel Disease

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cerebral Small Vessel Disease. Базовые параметры: от 18 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 →

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Обзор

The goal of this observational study is to learn about neuroimage and biomarkers in the cerebral small vessel disease. The main questions it aims to answer are: * How does neurovascular coupling change during the progression of CSVD? * How is the pattern/mapping of alterations in CSVD biomarkers? Participants will be observed and visit the research center annually to perform multi-modal MRI, PET, neuropsychological tests, and blood tests.

Подробное описание

This observational study recruits participants with cerebral small vessel disease (CSVD) from hospitals and community-based populations. Healthy volunteers will also be recruited as controls. Longitudinal follow-up of these participants will help clarify the significance of neuroimaging and biological biomarkers during the development and progression of CSVD.

The investigators aim to establish a longitudinal cohort covering the spectrum of CSVD and identify key biomarkers associated with disease progression and cognitive decline. All participants will undergo multimodal MRI, PET imaging (optional) with different tracers, and blood biomarker assessments. Using multimodal MRI, the investigators will investigate alterations in neurovascular coupling and their role in the pathophysiology of CSVD. In addition, PET imaging (optional) and blood biomarkers will be used to characterize the spatial and temporal patterns of disease-related biomarker changes. Furthermore, additional neuroimaging and digital biomarkers will be evaluated within the cohort to improve disease characterization and prognostic prediction.

Первичные конечные точки

  • Global cognitive ability [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Executive function [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Visual memory [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Short-term memory [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Executive memory [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Spatial executive function [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Naming ability [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Language ability [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Sleep quality [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Movement ability [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
Вторичные конечные точки (3)
  • Brain volume [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Connectivity integrity of the neural circuit [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]
  • Volume of white matter lesions [Срок оценки: baseline, 1 year, 2-year, 3-year, 5-year,10-year]

Критерии участия

Критерии включения

  • Age ≥18 years.
  • Evidence of cerebral small vessel disease (CSVD) on brain MRI, meeting at least one of the following imaging criteria:
  • White matter hyperintensities (WMH) with a total Fazekas score ≥2;
  • Fazekas score =1 with at least two vascular risk factors (hypertension, hyperlipidemia, diabetes mellitus, obesity, current smoking, or a history of vascular events other than stroke);
  • Fazekas score =1 accompanied by the presence of lacunes;
  • Imaging evidence of a recent subcortical lacunar infarction.
  • Independent in activities of daily living (modified Rankin Scale \[mRS\] ≤2).
  • Able and willing to provide written informed consent.

Критерии исключения

  • Acute ischemic stroke with a diffusion-weighted imaging (DWI) lesion >20 mm in diameter.
  • Acute intracerebral hemorrhage.
  • Acute subarachnoid hemorrhage, a history of aneurysmal subarachnoid hemorrhage or cerebrovascular malformation, or the presence of an untreated intracranial aneurysm >3 mm in diameter.
  • Previously diagnosed neurodegenerative disorders, such as Alzheimer's disease (AD) or Parkinson's disease (PD).
  • Definite non-vascular white matter diseases, including multiple sclerosis, adult-onset leukodystrophy, metabolic encephalopathy, or other non-vascular white matter disorders.
  • Major psychiatric disorders diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  • Contraindications to MRI (e.g., severe claustrophobia or MRI-incompatible implants).
  • Severe systemic diseases (e.g., active malignancy) with an expected life expectancy of less than 5 years.
  • Inability to complete scheduled follow-up because of geographic, logistical, or other reasons.
  • Concurrent participation in another interventional clinical trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07726654 · RJNeuroBank-SVD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗