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NCT03786939 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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