RCCS: Renji Cerebral Small Vessel Disease Corhort Study

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03544801
Collaborator
(none)
300
1
63
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Renji Cerebral Small Vessel Disease Corhort Study
    Actual Study Start Date :
    Sep 29, 2015
    Anticipated Primary Completion Date :
    Dec 30, 2020
    Anticipated Study Completion Date :
    Dec 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    sample group ,300

    CSVD patients after symptomatic stroke

    control group,100

    community population

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji Hospital,Shanghai Jiao Tong University School of Medicine Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Study Chair: qun xu, professor, RenJi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT03544801
    Other Study ID Numbers:
    • [2013012]
    First Posted:
    Jun 4, 2018
    Last Update Posted:
    Jun 4, 2018
    Last Verified:
    May 1, 2018

    Study Results

    No Results Posted as of Jun 4, 2018