NCT03786939

Brief Summary

Evaluation of outcomes of coronary artery bypass grafting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

November 21, 2023

Status Verified

October 1, 2023

Enrollment Period

6.4 years

First QC Date

December 20, 2018

Last Update Submit

November 20, 2023

Conditions

Ischemic Heart DiseaseCoronary Artery Bypass Grafting

Keywords

Ischemic Heart Diseasecoronary artery bypass graftingon-pump CABGoff-pump CABGpump - assisted CABGmyeloperoxidase after CABG

Outcome Measures

Primary Outcomes (1)

  • Death.

    Death during in-stay.

    30 days during in stay.

Secondary Outcomes (17)

  • Death over 1 year after CABG.

    1 year.

  • Death over 3 year after CABG.

    within 3 years.

  • Death over 5 year after CABG.

    within 5 years.

  • Acute myocardial infarction after CABG.

    within 30 days after CABG

  • Acute myocardial infarction after CABG.

    within 1 year after CABG

  • +12 more secondary outcomes

Study Arms (3)

On-pump CABG.

OTHER

On-pump CABG.

Procedure: On-pump CABG.

Off-pump CABG.

OTHER

Off-pump CABG.

Procedure: Off-pump CABG.

Pump-assisted CABG.

OTHER

Pump-assisted CABG.

Procedure: Pump-assisted CABG.

Interventions

On-pump CABG.PROCEDURE

On-pump coronary artery bypass grafting.

On-pump CABG.
Off-pump CABG.PROCEDURE

Off-pump coronary artery bypass grafting.

Off-pump CABG.
Pump-assisted CABG.PROCEDURE

Pump-assisted CABG.

Pump-assisted CABG.

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • valve disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Pavlov State Medical University

Saint Petersburg, 197089, Russia

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Alexander Nemkov, PhD

    First State Pavlov Medical University

    STUDY DIRECTOR

Central Study Contacts

Alexander Nemkov, PhD

CONTACT

+7-921-795-00-47nemk_as@mail.ru

Vladimir Komok, PhD

CONTACT

+7-904-632-19-00vladimir_komok@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 26, 2018

Study Start

December 20, 2018

Primary Completion

May 20, 2025

Study Completion

December 20, 2025

Last Updated

November 21, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Individual participant data are confidential.

Locations

RU(1)