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

June 20, 2018 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients over age 20 who are undergoing off-pump coronary artery bypass graft

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HMGB1 group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum value of HMGB1
Time Frame: 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:

  1. Stroke
  2. Renal failure
  3. Prolonged ventilation more than 24 hours
  4. Deep sternal wound infection
  5. Reoperation for any reason
  6. Mortality during the hospitalization for surgery, even if over 30 days
Change from induction of anesthesia to 2hrs after transfer to intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 16, 2017

Study Completion (Actual)

March 16, 2017

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2013-0341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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