NCT02206412

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2017

Completed
Last Updated

June 21, 2018

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

July 28, 2014

Last Update Submit

June 20, 2018

Conditions

Coronary Artery Occlusive Disease

Keywords

high mobility group box 1prognostic biomarkeroff-pump coronary artery bypass graftpatients

Outcome Measures

Primary Outcomes (1)

  • Maximum value of HMGB1

    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

Study Arms (1)

HMGB1 group

Eligibility Criteria

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

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

You may qualify if:

  • Age ≥ 20
  • Patients undergoing off-pump coronary artery bypass graft

You may not qualify if:

  • Age \< 20
  • Patients undergoing off-pump coronary artery bypass graft with other simultaneous surgery
  • Patients participating other study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine

Seoul, 120-752, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

July 28, 2014

First Posted

August 1, 2014

Study Start

July 1, 2014

Primary Completion

March 16, 2017

Study Completion

March 16, 2017

Last Updated

June 21, 2018

Record last verified: 2014-07

Locations

KR(1)