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The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

2026년 7월 21일 업데이트: Ruijin Hospital

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.

연구 개요

상태

아직 모집하지 않음

정황

대뇌소혈관질환

상세 설명

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.

연구 유형

관찰

등록 (추정된)

400

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

중국
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, 중국, 200025
    - Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    - 연락하다:
      
      Jingyan Tian, Dr
      
      전화번호: 13671865057
      
      이메일: tjy11488@rjh.com.cn
    - 수석 연구원:
      
      Jingwen Jiang, Dr.
    - 부수사관:
      
      Binyin Li, Dr.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

The population consists of vascular dementia, vascular mild cognitive impairment, and cognitively normal participants.

설명

Inclusion Criteria:

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.

Exclusion Criteria:

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
Cognitively Normal Participants do not have cognitive impairment.
Cerebral small vessel disease without dementia Participants have vascular cognitive impairment, but no cognitive impairment
Vascular Dementia (VaD) Participants have vascular cognitive impairment or difficulty in daily activity.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Global cognitive ability 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Mini-mental state examination	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive function 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Clock drawing test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Visual memory 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Rey-Osterich complex figure test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Short-term memory 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Auditory verbal learning test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive memory 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Symbol-digit test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Spatial executive function 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Trail making test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Naming ability 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Boston naming test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Language ability 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Language fluency test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Sleep quality 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Sleep disorder	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Movement ability 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Part III of the Unified Parkinson's Disease Rating Scale	baseline, 1 year, 2-year, 3-year, 5-year,10-year

2차 결과 측정

결과 측정	측정값 설명	기간
Brain volume 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Annual changes of volumes of brain	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Connectivity integrity of the neural circuit 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Annual changes of hippocampus related neural connectivity	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Volume of white matter lesions 기간: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Structural and functional MRI measures, including arterial spin labeling (ASL), diffusion MRI (dMRI), susceptibility-weighted imaging (SWI) and fluid-attenuated inversion recovery (FLAIR).	baseline, 1 year, 2-year, 3-year, 5-year,10-year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ruijin Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 8일

기본 완료 (추정된)

2028년 9월 30일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 7월 10일

QC 기준을 충족하는 최초 제출

2026년 7월 21일

처음 게시됨 (실제)

2026년 7월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)