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Ischemic Heart DiseaseEOCABGNCT03786939

Evaluation of Outcomes of Coronary Artery Bypass Grafting.

A study testing On-pump CABG., Off-pump CABG. and Pump-assisted CABG. in people with Ischemic Heart Disease and Coronary Artery Bypass Grafting, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluation of outcomes of coronary artery bypass grafting. Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
On-pump CABG., Off-pump CABG. and Pump-assisted CABG.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteRussia
Study dates
20 Dec 2018to 20 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • valve disease

Trial locations and contacts

1 site in 1 country.

Alexander Nemkov, PhD contact

+7-921-795-00-47

nemk_as@mail.ru

Vladimir Komok, PhD contact

+7-904-632-19-00

vladimir_komok@mail.ru

Russia1 site, 1 recruiting

  • First Pavlov State Medical University

    Saint Petersburg, 197089

    Vladimir Komok, Ph.D, +7 904 632 19 00, vladimir_komok@mail.ru

    Nikolay Bunenkov, +7 921 795 00 45, bunenkov2006@gmail.com

    Recruiting

Other trials in Russia

About this study

Evaluation of outcomes of coronary artery bypass grafting.

Read the 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.

Being tested
On-pump CABG., Off-pump CABG., Pump-assisted CABG.
Keywords
Ischemic Heart Disease, coronary artery bypass grafting, on-pump CABG, off-pump CABG, pump - assisted CABG, myeloperoxidase after CABG
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • On-pump CABG.Procedure or surgery

    On-pump coronary artery bypass grafting.

  • Off-pump CABG.Procedure or surgery

    Off-pump coronary artery bypass grafting.

  • Pump-assisted CABG.Procedure or surgery

    Pump-assisted CABG.

Study groups in NCT03786939
Study groupRoleWhat they receive
On-pump CABG.OtherOn-pump CABG.
Receives: Procedure: On-pump CABG.
Off-pump CABG.OtherOff-pump CABG.
Receives: Procedure: Off-pump CABG.
Pump-assisted CABG.OtherPump-assisted CABG.
Receives: Procedure: Pump-assisted CABG.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death.

    Death during in-stay.

    Measured: 30 days during in stay.

Secondary outcomes (17)

  1. Death over 1 year after CABG.

    Death over 1 year after CABG.

    Measured: 1 year.

  2. Death over 3 year after CABG.

    Death over 3 year after CABG.

    Measured: within 3 years.

  3. Death over 5 year after CABG.

    Death over 5 year after CABG.

    Measured: within 5 years.

  4. 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).

    Measured: within 30 days after CABG

  5. Acute myocardial infarction after CABG.

    Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).

    Measured: within 1 year after CABG

  6. Acute myocardial infarction after CABG.

    Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).

    Measured: within 3 years after CABG

  7. Acute myocardial infarction after CABG.

    Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).

    Measured: within 5 years after CABG

  8. Shunt dysfunction during 30 days after CABG.

    Criteria: Stenosis or occlusion of graft on coronary angiography.

    Measured: within 30 days after CABG

  9. Shunt dysfunction during 1 year after CABG.

    Criteria: Stenosis or occlusion of graft on coronary angiography.

    Measured: within 1 year after CABG

  10. Shunt dysfunction during 3 years after CABG.

    Criteria: Stenosis or occlusion of graft on coronary angiography.

    Measured: within 3 years after CABG

  11. Shunt dysfunction during 5 years after CABG.

    Criteria: Stenosis or occlusion of graft on coronary angiography.

    Measured: within 5 years after CABG

  12. Stroke.

    Stroke after CABG (Record of neurologist in medical history or/and MRI findings).

    Measured: within 30 days after CABG

  13. Renal Dysfunction.

    Increase serum creatinine level greater than 25% of reference value after CABG.

    Measured: within 30 days after CABG

  14. Atrial fibrillation.

    New onset of atrial fibrillation after CABG (ECG findings: f-waves).

    Measured: within 30 days after CABG

  15. IABP

    Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index <2.3))

    Measured: within 30 days after CABG

  16. 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).

    Measured: within 30 days after CABG

  17. Residual myocardial ischemia.

    New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion).

    Measured: within 30 days after CABG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2018
  2. Study start20 Dec 2018
  3. Primary completion20 May 2025 (estimated)
  4. Study completion20 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03786939
Sponsor's protocol ID
EOCABG
Acronym
EOCABG
Status last verified
Oct 2023
First submitted
20 Dec 2018
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are confidential.

Questions about this trial

What is this clinical trial studying?

A study testing On-pump CABG., Off-pump CABG. and Pump-assisted CABG. in people with Ischemic Heart Disease and Coronary Artery Bypass Grafting, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexander Nemkov, PhD (+7-921-795-00-47, nemk_as@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death. (time frame: 30 days during in stay.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03786939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.

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