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Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD

Sponsor
wangqiang (Other)
Overall Status
Unknown status
CT.gov ID
NCT02164669
Collaborator
(none)
20
Enrollment
1
Location
13
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of POCD.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Postoperative cognitive dysfunction (POCD) is one of the most common complications in patients undergoing cardiac surgery. POCD will not only increase the incidence of complications and mortality, but also influence the quality of life after discharging from the hospital. Many factors are associated with POCD, such as neuroinflammation, age, anesthetics, surgery stress response and genetic factors. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI, which could monitor the peripheral neuron spontaneous activity according to the ratio of oxyhemoglobin and deaeration hemoglobin in blood, will be used to investigate whether POCD is induced by the variance in neurons metabolism and spontaneous activity in brain regions. Meanwhile, biochemical indicators will be detected to explore the prompting indicators of POCD. The present study is aimed to represent a promising precursory target for diagnosis and treatment of POCD, and provide novel evidence and insights on the brain changes induced by POCD.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exploration of Neuroimaging and Biochemical Prognostic Indicators for Post-operative Cognitive Dysfunction After Coronary Artery Bypass Graft
    Study Start Date :
    May 1, 2013
    Anticipated Primary Completion Date :
    Jun 1, 2014
    Anticipated Study Completion Date :
    Jun 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. The brain structure changes [7 days postoperatively]

      Using BOLD fMRI to investigate the variance of mean diffusivity and FA in nerve conduction bundle

    Secondary Outcome Measures

    1. Mini-Mental State Examination [preoperative and 7 days, 3 months and 1 years postoperative]

      Application of digital depth and breadth to test digital sign test Tracking the attachment test and assess depression self rating scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged 18-80 years old

    • Underwent selective CABG surgery

    Exclusion Criteria:

    • History of central nervous system or psychiatric disorders

    • History of taking sedative, antidepressants, or alcoholism

    • MMSE score less than 23

    • Visual or auditory disorders

    • Educated less than 7 years

    • Claustrophobia

    • Can not be supine

    • Can not tolerate iodinated contrast agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijign Hospital Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • wangqiang

    Investigators

    • Study Director: Qiang Wang, MD, PhD, Xijing Hospital
    • Principal Investigator: Zijun Gao, Dr., Xijing Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    wangqiang, Professor, Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT02164669
    Other Study ID Numbers:
    • 20130225-8
    First Posted:
    Jun 16, 2014
    Last Update Posted:
    Jun 16, 2014
    Last Verified:
    May 1, 2013
    Keywords provided by wangqiang, Professor, Xijing Hospital
    Inflammation
    Coronary artery bypass graft
    Magnetic Resonance Imaging
    Additional relevant MeSH terms:
    Postoperative Cognitive Complications
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Jun 16, 2014