The Association of Omentin and Ischemic Stroke

Sponsor
Xi'an No.3 Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03125759
Collaborator
(none)
2,000
1
108
18.5

Study Details

Study Description

Brief Summary

This observational study aims to research whether there is a relationship between omentin and ischemic stroke on the aspects of incidence, severity, and recovery etc.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To study the possible relationship between omentin and ischemic stroke, we intend to recruit the newly found acute ischemic stroke patients and patients without any stroke history and analysis the difference of plasma omentin level and the ITLN, which is the gene symbol of omentin.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Association of Omentin and Ischemic Stroke
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    patients without any history of stroke

    Ischemic Stroke

    patients with an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction within 72 hours.

    Outcome Measures

    Primary Outcome Measures

    1. the odds ratio of omentin plasma concentration between cases and controls [up to 3 years]

      The circulation level of omentin will be assessed in cases and controls. Then the odds ratio will be statically analysed to detect whether omentin is asociated with ischemic stroke on protein level.

    2. the frequency difference of single nucleotide polymorphism(SNP) of omentin in the enrolled subjects [up to 3 years]

      The SNP will be analysed in the recruited subjects. And the the frequency difference will be calculated to explore if any SNP is related to ischemic stroke.

    Secondary Outcome Measures

    1. the NIHSS assessed for functional outcome of stroke [up to 3 years]

      NIHSS wil be used to assess neurological status at baseline or the point of stroke, the point of out-patient, 3 month, 6 month, 1 year, 2 year and the 3 year.

    2. the modified Rankin Scale assessed for functional disability [up to 3 years]

      Th functional disability will be assessed using the modified Rankin Scale at the time of baseline, out-patient, 3rd month, 6th month, 1st year, 2nd year and the 3rd year after enrollment.

    3. the Barthel index assessed for functional independence in activities [up to 3 years]

      The Barthel index at the point of baseline, out-patient, 3rd month, 6th month, 1st year, 2nd year and the 3rd year after enrollment will be assessed for the functional independence in activities.

    4. the number of all cause death [up to 3 years]

      The number of all cause of death will be recorded in both groups.

    5. the number of re-stroke in case group [up to 3 years]

      Recurrent of stroke will be monitored through out in case group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • For ischemic stroke group,acute clinically defined ischemic stroke

    • For control group, without any history of stroke

    Exclusion Criteria:

    For ischemic stroke group

    • Hemorrhagic Stroke

    • Previous Ischemic Stroke For control group

    • The expected life expense less than 3 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xi'an No.3 Hospital Xi'an Shanxi China 710018

    Sponsors and Collaborators

    • Xi'an No.3 Hospital

    Investigators

    • Principal Investigator: Tian Ye, PhD, Xi'an No.3 Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xi'an No.3 Hospital
    ClinicalTrials.gov Identifier:
    NCT03125759
    Other Study ID Numbers:
    • NDIS001
    First Posted:
    Apr 24, 2017
    Last Update Posted:
    Apr 24, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Xi'an No.3 Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 24, 2017