Results of Coronary Artery Bypass Grafting in Obese Patients
1 other identifier
observational
500
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedNovember 1, 2022
October 1, 2022
1.3 years
June 1, 2021
October 31, 2022
Conditions
Keywords
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
CABG-2
A group of obese patients (BMI over 30 kg / m2) who underwent isolated coronary artery bypass grafting for chronic ischemic heart disease
Interventions
Coronary artery bypass surgery is a surgical procedure to restore normal blood flow to an obstructed or stenotic coronary artery.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrey S Pryakhin, PhD
Tomsk NRMC
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