Evaluation of Outcomes of Coronary Artery Bypass Grafting.

Not Applicable

Recruiting

• Conditions: Ischemic Heart Disease; Coronary Artery Bypass Grafting
• Interventions: Procedure: On-pump CABG.; Procedure: Off-pump CABG.; Procedure: Pump-assisted CABG.

• Registration Number: NCT03786939
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief Summary

Evaluation of outcomes of coronary artery bypass grafting.

Detailed Description

Evaluation of outcomes of coronary artery bypass grafting (CABG) on-, off- pump, pump assisted as well as bimammary coronary artery bypass grafting.

Objective:

To assess myocardial ischemic-reperfusion damage during different kinds of CABG.

To assess complications after during different kinds of CABG.

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-05-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Ischemic heart disease with indications for coronary artery bypass grafting.

Exclusion Criteria

• valve disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
On-pump CABG.	On-pump CABG.	On-pump CABG.
Off-pump CABG.	Off-pump CABG.	Off-pump CABG.
Pump-assisted CABG.	Pump-assisted CABG.	Pump-assisted CABG.

Primary Outcome Measures

Name	Time	Method
Death.	30 days during in stay.	Death during in-stay.

Secondary Outcome Measures

Name	Time	Method
Death over 5 year after CABG.	within 5 years.	Death over 5 year after CABG.
Acute myocardial infarction after CABG.	within 5 years after CABG	Acute myocardial infarction (Criteria: troponin I\>0.05+ST-elevation on ECG).
Death over 1 year after CABG.	1 year.	Death over 1 year after CABG.
Death over 3 year after CABG.	within 3 years.	Death over 3 year after CABG.
Shunt dysfunction during 30 days after CABG.	within 30 days after CABG	Criteria: Stenosis or occlusion of graft on coronary angiography.
Shunt dysfunction during 3 years after CABG.	within 3 years after CABG	Criteria: Stenosis or occlusion of graft on coronary angiography.
Shunt dysfunction during 5 years after CABG.	within 5 years after CABG	Criteria: Stenosis or occlusion of graft on coronary angiography.
Shunt dysfunction during 1 year after CABG.	within 1 year after CABG	Criteria: Stenosis or occlusion of graft on coronary angiography.
Stroke.	within 30 days after CABG	Stroke after CABG (Record of neurologist in medical history or/and MRI findings).
Renal Dysfunction.	within 30 days after CABG	Increase serum creatinine level greater than 25% of reference value after CABG.
Atrial fibrillation.	within 30 days after CABG	New onset of atrial fibrillation after CABG (ECG findings: f-waves).
IABP	within 30 days after CABG	Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index \<2.3))
Infection or febrile.	within 30 days after CABG	Infection or febrile (leucocytosis \> 9.0 more than 7 days after CABG or CRP \> 10 or t\>37.0 more than 7 days after CABG).
Residual myocardial ischemia.	within 30 days after CABG	New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion).

Trial Locations

Locations (1)

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