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Renji Cerebral Small Vessel Disease Corhort Study (RCCS)

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Cognition Disorders
Cerebrovascular Disorders

Study type

Observational

Funder types

Other

Identifiers

NCT03544801
[2013012]

Details and patient eligibility

About

We aim to make clear the impact with the mechanisms of variant pathological injuries on the outcomes of CSVD, to find independent imaging markers and establish prediction model of it.

Full description

A cohort of post stroke cerebral small vessel disease (CSVD) patients with different cognitive status are consecutively recruited in this study. Detailed full domain cognitive assessment and multi-modal MRI (including brain morphology , DTI indices, microbleed counts, brain volumes as well as brain network characters, etc.) are performed. Cognitive states(including attention-executive function, memory, language, visuo-spatial and global cognition with the transition to dementia) and the overall prognosis (cardiovascular events, stroke recurrence, death due to cardiovascular event and all cause death) are longitudinally followed up. The correlations between baseline and followed MRI parameters with the outcomes are analyzed in order to make clear the impact with the mechanisms of variant pathological injuries on the outcomes of CSVD, to find independent imaging markers and establish prediction model of it.

Enrollment

300 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • ①50-85 years; ② at least 6 years of education; ③ CSVD was defined as patients experienced a clinical lacunar stroke at least 1 months ago, and MRI showed responsible lacunar infarcts and white matter lesions; ④ Cooperate with cognitive tests; ⑤Not accept medications that affect cognition; ⑥. Score of modified Rankin scale ≦3; ⑦. Sign informed consent.

Exclusion criteria

  • ① Etiology due to cardioembolic or large vessel disease (>50% stenosis in extra- or intra-cerebral arteries); ② Non vasular white matter lesions(WMLs);③ Cortical and/or cortico-subcortical non-lacunar infarct; ④ Other cognitive diseases (such as Alzheimer's disease, Parkinson disease or thyroid disease, etc. ) ⑤Severe systemic diseases such as heart, liver and kidney diseases or major psychiatric disorders; ⑥Severe depressive state: Hamilton depression rating scale score >24; ⑦ MRI contraindications.

Trial design

300 participants in 2 patient groups

sample group ,300
Description:
CSVD patients after symptomatic stroke
control group,100
Description:
community population

Trial contacts and locations

1

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Central trial contact

qun xu, professor

Data sourced from clinicaltrials.gov

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