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Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Off-pump Coronary Artery Bypass Graft

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02206412
Collaborator
(none)
255
Enrollment
1
Location
32.5
Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is released by inflammatory cells actively, or increased during cell death passively and mediates inflammatory response. It has been reported to have association with the prognosis after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    255 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Study Start Date :
    Jul 1, 2014
    Actual Primary Completion Date :
    Mar 16, 2017
    Actual Study Completion Date :
    Mar 16, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    HMGB1 group

    Outcome Measures

    Primary Outcome Measures

    1. Maximum value of HMGB1 [Change from induction of anesthesia to 2hrs after transfer to intensive care unit]

      Measure the maximum value of HMGB1 in all patients and calculate median value. And device into upper median value group and under median value group and compare frequency of composite morbidity/mortality rate between two groups. composite morbidity/mortality is as follows: Stroke Renal failure Prolonged ventilation more than 24 hours Deep sternal wound infection Reoperation for any reason Mortality during the hospitalization for surgery, even if over 30 days

    Eligibility Criteria

    Criteria

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

    1. Age ≥ 20

    2. Patients undergoing off-pump coronary artery bypass graft

    Exclusion Criteria:

    1. Age < 20

    2. Patients undergoing off-pump coronary artery bypass graft with other simultaneous surgery

    3. Patients participating other study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02206412
    Other Study ID Numbers:
    • 4-2013-0341
    First Posted:
    Aug 1, 2014
    Last Update Posted:
    Jun 21, 2018
    Last Verified:
    Jul 1, 2014
    Keywords provided by Yonsei University
    high mobility group box 1
    prognostic biomarker
    off-pump coronary artery bypass graft
    patients

    Study Results

    No Results Posted as of Jun 21, 2018