Evaluation of Outcomes of Coronary Artery Bypass Grafting.

Ischemic Heart Disease Clinical Trial

— EOCABG  

Official title:

Evaluation of Outcomes of Coronary Artery Bypass Grafting.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786939
• Other study ID #: EOCABG
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: December 20, 2025

Study information

• Verified date: October 2023
• Source: St. Petersburg State Pavlov Medical University
• Contact: Alexander Nemkov, PhD
• Phone: +7-921-795-00-47
• Email: nemk_as[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of outcomes of coronary artery bypass grafting.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 20, 2025
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• valve disease

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• On-pump CABG.
On-pump coronary artery bypass grafting.
• Off-pump CABG.
Off-pump coronary artery bypass grafting.
• Pump-assisted CABG.
Pump-assisted CABG.

Locations

Country	Name	City	State
Russian Federation	First Pavlov State Medical University	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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