NCT04834219

Brief Summary

CABG (coronary artery bypass graft) surgery is among the most common heart surgeries performed in the heart pump. In CABG surgery, operations performed on the beating heart without the use of CPB (off-pump) are frequently performed (30-60%) (1). To the best of our knowledge, there has been no study examining cerebral oxygenation values, oxidative stress levels and postoperative results in CABG operations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 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 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

April 2, 2021

Last Update Submit

September 24, 2021

Conditions

Keywords

Coronary artery bypass surgeryOxidative stressCerebral oxygenation

Outcome Measures

Primary Outcomes (4)

  • Oxidative stress level

    Oxidative stress biomarker levels between on-pump and off-pump coronary artery bypass groups

    Intraoperative period

  • TAS

    Total antioxidant status

    Intraoperative period

  • TOS

    Total oxidant status

    Intraoperative period

  • SOD

    Superoxide dismutase

    Intraoperative period

Secondary Outcomes (1)

  • Cerebral oximetry

    Intraoperative period

Study Arms (2)

On-pump CABG

Patients with an on-pump indication by the cardiovascular surgery department will be included in the study.

Procedure: On-Pump CABGProcedure: Off-Pump CABG

Off-pump CABG

Patients with an off-pump indication by the cardiovascular surgery department will be included in the study.

Procedure: On-Pump CABGProcedure: Off-Pump CABG

Interventions

On-Pump CABGPROCEDURE

Patients who have undergone on-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.

Off-pump CABGOn-pump CABG
Off-Pump CABGPROCEDURE

Patients who have undergone off-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.

Off-pump CABGOn-pump CABG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It is planned to participate in this prospective observational study of 64 volunteer patients undergoing Coronary artery bypass grafting (CABG) surgery by the Department of Cardiovascular Surgery.

You may qualify if:

  • Undergo CABG surgery with on-pump and off-pump technique,
  • Volunteer to participate in the study,
  • years old

You may not qualify if:

  • Those with chronic kidney failure
  • Those with liver failure
  • Under 30 and over 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bozok University Medical Center

Yozgat, Turkey (Türkiye)

Location

Related Publications (1)

  • Hussain G, Azam H, Baig MA, Ahmad N. Early outcomes of on-pump versus off-pump coronary artery bypass grafting. Pak J Med Sci. 2016 Jul-Aug;32(4):917-21. doi: 10.12669/pjms.324.9680.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ökkeş Hakan Miniksar, Asist.Prof

    YOZGAT BOZOK UNIVERSITY

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 8, 2021

Study Start

January 15, 2021

Primary Completion

September 15, 2021

Study Completion

September 24, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations