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The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

21. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Zerebrale Erkrankung der kleinen Gefäße

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

400

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

China
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200025
    - Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    - Kontakt:
      
      Jingyan Tian, Dr
      
      Telefonnummer: 13671865057
      
      E-Mail: tjy11488@rjh.com.cn
    - Hauptermittler:
      
      Jingwen Jiang, Dr.
    - Unterermittler:
      
      Binyin Li, Dr.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Global cognitive ability Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Brain volume Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ruijin Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

8. Juli 2026

Primärer Abschluss (Geschätzt)

30. September 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

10. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)