NCT02490644

Brief 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. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

June 30, 2015

Last Update Submit

January 27, 2019

Conditions

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

  • concentration of HMGB1

    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

Study Arms (1)

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

Interventions

Blood samplingPROCEDURE

Blood sampling 5ml

MGB1 in valvular heart surgery

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people who undergo valvular heart surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 7, 2015

Study Start

January 12, 2015

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

KR(1)