Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery

January 27, 2019 updated by: Yonsei University
One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

High-mobility group protein B1 (HMGB1) is a protein which is encoded by the HMGB1 gene in human. HMGB1 is secreted by immune cells (like macrophages, monocytes and dendritic cells). Activated macrophages and monocytes secrete HMGB1 as a cytokine mediator of Inflammation. There are many studies suggesting the relationship between HMGB1 and acute coronary syndrome, myocardial ischemic/reperfusion injury, atherosclerosis, heart failure and other cardiac disease as a marker for inflammatory response. However, there are no other study evaluating HMGB1 as a prognostic factor after valvular surgery, so far.

Study Type

Observational

Enrollment (Actual)

250

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 and Pain Medicine, Anesthesia and Pain Research Institute, 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

Non-Probability Sample

Study Population

people who undergo valvular heart surgery

Description

Inclusion Criteria:

  • age ≥ 20
  • patients undergoing aortic valve surgery or more than single valve surgery

Exclusion Criteria:

  • age < 20
  • patients undergoing single mitral valve surgery
  • history of open heart surgery
  • emergency surgery
  • history of steroid medication
  • infective disease and/or malignant tumor
  • coronary artery bypass surgery or aortic replacement surgery

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
Intervention / Treatment
MGB1 in valvular heart surgery
Evaluation of the high mobility group box 1 as a prognostic biomarker in patients undergoing valvular heart surgery
Procedure: Blood sampling
Blood sampling 5ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of HMGB1
Time Frame: collect blood sample right before the surgery after induction of anesthesia
The relationship between concentration of HMGB1 and post op prognosis in patients undergoing valvular heart surgery
collect blood sample right before the surgery after induction of anesthesia

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

January 12, 2015

Primary Completion (Actual)

September 29, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 27, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0764

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.

Clinical Trials on Valvular Heart Disease

Clinical Trials on Blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe