Valvular Heart DiseaseNCT02490644
Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery
An observational study of Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2015to 29 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people who undergo valvular heart surgery
Who may be able to join
- age ≥ 20
- patients undergoing aortic valve surgery or more than single valve surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
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.
Read the 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.
- Conditions
- Valvular Heart Disease
- Being tested
- Blood sampling
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sampling 5ml
| Study group | Role | What they receive |
|---|---|---|
| MGB1 in valvular heart surgery | Evaluation of the high mobility group box 1 as a prognostic biomarker in patients undergoing valvular heart surgery Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of HMGB1
The relationship between concentration of HMGB1 and post op prognosis in patients undergoing valvular heart surgery
Measured: collect blood sample right before the surgery after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study start12 Jan 2015
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490644
- Sponsor's protocol ID
- 4-2014-0764
- Status last verified
- Jan 2019
- First submitted
- 30 Jun 2015
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT02490644
- Acronym / sponsor ID
- 4-2014-0764
- Conditions
- Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Jan 2015
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGB1 in valvular heart surgery | – | Procedure: Blood samplingEvaluation of the high mobility group box 1 as a prognostic biomarker in patients undergoing valvular heart surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people who undergo valvular heart surgery
Key inclusion criteria (2 listed)
- age ≥ 20
- patients undergoing aortic valve surgery or more than single valve surgery
Key exclusion criteria (7 listed)
- age < 20
- patients undergoing single mitral valve surgery
- history of open heart surgery
- emergency surgery
- history of steroid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling 5ml | Procedure or surgery | MGB1 in valvular heart surgery |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of HMGB1 (time frame: collect blood sample right before the surgery after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.