Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

Completed

• Conditions: Ischemic Heart Disease; Coronary Artery Disease; Ischemic Reperfusion Injury; CABG
• Interventions: Procedure: On-Pump CABG.; Procedure: Off-Pump CABG.; Procedure: BH-CABG MSC.

• Registration Number: NCT03050489
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief Summary

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.

Detailed Description

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG is monitored by intraoperative measurement of serum level of myeloperoxidase before sternotomy and after sternal closure.

Study Timeline

• Study Start: 2015-09-15
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-13
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Results First Submitted: 2021-06-18
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Results First Posted: 2023-01-13
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• ischemic heart disease

Exclusion Criteria

• valve disease
• diabetes millitus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
On-Pump CABG	On-Pump CABG.	Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass.
Off-Pump CABG	Off-Pump CABG.	Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass.
BH-CABG MSC.	BH-CABG MSC.	Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation.

Primary Outcome Measures

Name	Time	Method
Myeloperoxidase	Level of serum myeloperoxidase just after sternal closure	Level of serum myeloperoxidase just after sternal closure

Secondary Outcome Measures

Name	Time	Method
Length of Stay in Intensive Care Unit	During 30 days after procedure or more	Length of stay in intensive care unit after operation.
Diastolic Function	Up to 14 days after surgical procedure	Measured with echocardiography (End-Diastolic Volume)
Atrial Fibrillation.	Up to 30 days after procedure	New onset atrial fibrillation after operation.
Pulmonary Ventilation	During 30 days after procedure or more	Length of pulmonary ventilation
Systolic Function	Up to 14 days after surgical procedure	Measured with echocardiography (Ejection Fraction)
Renal Dysfunction	Perioperative (before sternotomy and after sternal closure)	Serum creatinine level after surgical operation larger than 25% level before operation
Cumulative Dose of Inotrope	Up to 30 days after procedure	Calculated according: Cumulative dose of inotrope = Days dose of inotrope \* days of administration of inotrope
Low Cardiac Output Syndrome	Up to 30 days after surgical procedure	Low cardiac output syndrome up to 30 days after procedure. Cardiac index (CI) was measured by invasive methods. Low cardiac output syndrome was registered when CI \<2.2.
Length of Stay in Hospital	During 30 days after procedure or more	Length of stay in hospital
Days of Administration of Inotrope	During 30 days after procedure or more	Period of inotrope administration
Number of Participants With Reoperation	Up to 30 days after procedure	Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index\<2.2.

Trial Locations

Locations (1)

First Pavlov State Medical University of St. Petersburg; 🇷🇺 St. Petersburg, Russian Federation