NCT04916912

Brief Summary

This study is planned to assess the effect of obesity (BMI over 30 kg / m2) on hospital outcomes of isolated coronary artery bypass grafting in patients with chronic ischemic heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

June 1, 2021

Last Update Submit

October 31, 2022

Conditions

Keywords

Chronic Ischemic Heart DiseaseObesitycoronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

  • Death

    In-hospital mortality rate (%)

    30 days

Secondary Outcomes (8)

  • neurological injury

    30 days

  • acute kidney injury

    30 days

  • Duration of mechanical ventilation

    30 days

  • re-exploration

    30 days

  • postoperative transfusion

    30 days

  • +3 more secondary outcomes

Study Arms (2)

CABG-1

A group of non-obese patients (BMI less than 30 kg / m2) who underwent isolated coronary artery bypass grafting for chronic ischemic heart disease

Procedure: coronary artery bypass grafting

CABG-2

A group of obese patients (BMI over 30 kg / m2) who underwent isolated coronary artery bypass grafting for chronic ischemic heart disease

Procedure: coronary artery bypass grafting

Interventions

Coronary artery bypass surgery is a surgical procedure to restore normal blood flow to an obstructed or stenotic coronary artery.

Also known as: CABG
CABG-1CABG-2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being living in Russian Federation (inc. ethnic minorities) with chronic ischemic heart disease and indications for cardiac surgery

You may qualify if:

  • Clinical diagnosis of chronic ischemic heart disease
  • Indications for cardiac surgery
  • Stenosis of more than 75% of the trunk of the left coronary artery, or proximal stenosis of the anterior descending artery and/or stenosis of more than 75% of two or more coronary arteries

You may not qualify if:

  • The presence of organic heart defects of rheumatic and infectious etiology;
  • Acute myocardial infarction;
  • Less than 3 months after acute coronary or cerebrovascular events;
  • Severe pulmonary hypertension not associated with mitral regurgitation (above 75 mmHg);
  • Contraindications for operations with cardiopulmonary bypass;
  • Severe course of bronchial asthma,
  • Chronic obstructive pulmonary disease in the acute stage;
  • Refusal of the patient or relatives to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrey Pryakhin

Tomsk, Tomsk State, 634012, Russia

Location

MeSH Terms

Conditions

Obesity

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Andrey S Pryakhin, PhD

    Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 8, 2021

Study Start

May 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations