Renji Cerebral Small Vessel Disease Corhort Study

• Conditions: Cerebrovascular Disorders; Cognition Disorders

• Registration Number: NCT03544801
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-09-29
• Status Verified: 2018-05
• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-05-31
• Last Update Submitted: 2018-05-31
• Study First Posted: 2018-06-04
• Last Update Posted: 2018-06-04
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a predictive model	2015,July---	The occurrence, development and predictive imaging markers of cognitive impairment and overall outcomes in post stroke patients with cerebral small vessel diseases.

Trial Locations

Locations (1)

Renji Hospital,Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China