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The Effect of Carotid IMT (Intima Media Thickness) on Postoperative Cognitive Dysfunction in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02456493
Collaborator
(none)
224
Enrollment
1
Location
45.3
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The patients who have undergone cardiac surgery have higher likelihood of postoperative cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by preoperative B-mode ultrasonography. The cognitive function measured by K-MMSE, MOCA-K before the operation, and on the 7 day, 3 months after operation. The patients in the non-surgical group are measured three times: baseline, after 7days, after 3 months.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    224 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Jun 29, 2015
    Actual Primary Completion Date :
    Apr 8, 2019
    Actual Study Completion Date :
    Apr 8, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    increased carotid IMT group

    Patients who have increased carotid IMT (intima media thickness)
    normal carotid IMT group

    Patients who have normal carotid IMT

    Outcome Measures

    Primary Outcome Measures

    1. postoperative cognitive dysfunction [7 days after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who are scheduled to undergo OPCAB
    Exclusion Criteria:

    • severe cognitive dysfunction

    • disabling mental change disorder

    • unable to communicate or speak Korean

    • do not have carotid IMT measurement.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, 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:
    NCT02456493
    Other Study ID Numbers:
    • 4-2015-0254
    First Posted:
    May 28, 2015
    Last Update Posted:
    May 10, 2019
    Last Verified:
    May 1, 2019

    Study Results

    No Results Posted as of May 10, 2019