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MRIPND: MRI Maker of Perioperative Neurocognitive Disorder

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03773627
Collaborator
(none)
100
Enrollment
1
Location
19.6
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. The purpose of this study is trying to find the functional MRI marker of PND.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery
    Actual Study Start Date :
    Dec 12, 2018
    Anticipated Primary Completion Date :
    Dec 30, 2019
    Anticipated Study Completion Date :
    Jul 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. MRI markers of PND before 7th day after surgery [From the day before surgery to the 7th day after surgery]

      To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 7th day after surgery

    Secondary Outcome Measures

    1. MRI markers of PND before 12 month after surgery [From the 7th day after surgery to 12 month after surgery]

      To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 12 months after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 60 years

    • Spoke proficient Chinese

    • Selected to lower limb osteopathic surgery

    • Informed consent signed by the patient

    • Underwent general anesthesia

    Exclusion Criteria:

    • Existing cerebral disease, or have a history of neurological and psychiatric diseases including AD, stroke, and psychosis

    • Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24

    • Several audition or vision disorder

    • With standard contraindications to MRI examinations

    • Unwillingness to comply with the protocol or procedures.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji Hospital Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Study Director: qi lu, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT03773627
    Other Study ID Numbers:
    • 2017-075
    First Posted:
    Dec 12, 2018
    Last Update Posted:
    Dec 13, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis, Knee
    Necrosis

    Study Results

    No Results Posted as of Dec 13, 2018