The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital
ConditionCerebral Small Vessel Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years.
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;
Disqualifiers
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).
Trial population
The population consists of vascular dementia, vascular mild cognitive impairment, and cognitively normal participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 3 trial groupsGroup A: Cognitively Normal
Group B: Cerebral small vessel disease without dementia
Group C: Vascular Dementia (VaD)
Trial outcomes
Primary outcomes
1
Global cognitive ability
Mini-mental state examination
Time frame
baseline, 1 year, 2-year, 3-year, 5-year,10-year2
Executive function
Clock drawing test
Time frame
baseline, 1 year, 2-year, 3-year, 5-year,10-year3
Visual memory
Rey-Osterich complex figure test
Time frame
baseline, 1 year, 2-year, 3-year, 5-year,10-year4
Short-term memory
Auditory verbal learning test
Time frame
baseline, 1 year, 2-year, 3-year, 5-year,10-yearSecondary outcomes
1
Brain volume
Annual changes of volumes of brain
Time frame
baseline, 1 year, 2-year, 3-year, 5-year,10-year2
Connectivity integrity of the neural circuit
Annual changes of hippocampus related neural connectivity
Time frame
baseline, 1 year, 2-year, 3-year, 5-year,10-year3
Volume of white matter lesions
Structural and functional MRI measures, including arterial spin labeling (ASL), diffusion MRI (dMRI), susceptibility-weighted imaging (SWI) and fluid-attenuated inversion recovery (FLAIR).
Time frame
baseline, 1 year, 2-year, 3-year, 5-year,10-yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: