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Functional Prognosis of Post-operative Patients With Cerebral Small Vascular Disease(CSVD)

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05359588
Collaborator
(none)
212
Enrollment
1
Location
12
Anticipated Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators perform a retro-prospective exploratory cohort study among patients 65 to 85 years old with pre-operative head MRI result after thoracic surgery in Renji Hospital Affiliated to Shanghai Jiaotong University from November 2020 to December 2021. Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, etc.), perioperative indicators （use of anesthetics, anesthetic time, blood pressure, etc.）, postoperative cerebral function follow-up and occurrence of cerebral vascular complications (brain infarction, brain bleed, etc.) of patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    212 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Association Between Postoperative Cerebral Vascular Complication and Functional Prognosis and Cerebral Small Vascular Disease (CSVD) After Thoracic Surgery : an Exploratory Study
    Actual Study Start Date :
    Jan 31, 2022
    Anticipated Primary Completion Date :
    Jan 31, 2023
    Anticipated Study Completion Date :
    Jan 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative overt stroke [1 year after surgery]

      Postoperative overt stroke detected by MRI of the brain

    Secondary Outcome Measures

    1. Physical function after surgery as assessed using Activities of Daily Living (iADL) Scale [1 year after surgery]

      score of Activity of Daily Living Scale with total score of 78, higher score, better function) and Modified Ranking Scale from 0(no symptomatic post-infarction complication ) to 6 (death after cerebral infaction)

    2. Physical function after surgery as assessed using the Modified Rankin Scale [1 year after surgery]

      The scale runs from 0-6, running from perfect health without symptoms to death. A higher score is worse.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 65≤age<85

    • after thoracic surgery

    • finish pre-operative brain MRI

    Exclusion Criteria:

    • mental illness

    • existing dementia and other diseases: Alzheimer disease, dementia, Parkinson's disease, Huntington's disease, systemic lupus erythematosus, etc.

    • previous cerebral infarction or hemorrhage

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05359588
    Other Study ID Numbers:
    • CSVD2021
    First Posted:
    May 4, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cerebral Small Vessel Diseases
    Vascular Diseases
    Long Term Adverse Effects

    Study Results

    No Results Posted as of May 4, 2022