Evaluation of Outcomes of Coronary Artery Bypass Grafting. (EOCABG)

November 20, 2023 updated by: St. Petersburg State Pavlov Medical University
Evaluation of outcomes of coronary artery bypass grafting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexander Nemkov, PhD
  • Phone Number: +7-921-795-00-47
  • Email: nemk_as@mail.ru

Study Contact Backup

Study Locations

  • Russian Federation
      • St. Petersburg, Russian Federation, 197089
        • Recruiting
        • First Pavlov State Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolai Bunenkov
        • Sub-Investigator:
          • Aleksey Sokolov, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • valve disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: On-pump CABG.
Procedure: On-pump CABG.
On-pump coronary artery bypass grafting.
Other: Off-pump CABG.
Procedure: Off-pump CABG.
Off-pump coronary artery bypass grafting.
Other: Pump-assisted CABG.
Procedure: Pump-assisted CABG.
Pump-assisted CABG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death.
Time Frame: 30 days during in stay.
Death during in-stay.
30 days during in stay.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Investigators

  • Study Director: Alexander Nemkov, PhD, First State Pavlov Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2018

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOCABG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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