ObesityNCT06614023
Impact of Body Weight on Outcomes of Patients Undergoing Coronary Artery Bypass Grafting
An observational study of Obesity and Coronary Artery Disease, run by Medical University of Silesia.
Trial summary
All consecutive patients who underwent isolated coronary artery bypass grafting (CABG) at our institution from 2014 to 2020 were included. Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \<20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Coronary Artery Disease, Angina Pectoris
- What is being tested?
- coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 6,448 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Feb 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients undergoing isolated CABG
Who may be able to join
- patients undergoing isolated CABG
Who cannot join
- any concomitant additional surgical procedures
About this study
Official title: Impact of Body Mass Index on Mortality in Patients Undergoing Coronary Artery Bypass Grafting: a Retrospective Cohort Study
All consecutive patients who underwent isolated coronary artery bypass grafting (CABG) at our institution from 2014 to 2020 were included. Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \<20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI \>40 kg/m2). The long-term mortality was analyzed as primary end-point. The univariable and multivariable analysis was performed using logistic regression modeling.
Read the detailed description
All consecutive patients aged above eighteen who underwent isolated CABG were enrolled. Patients operated on- and off-pump were included. We reviewed elective, urgent, emergency and salvage surgeries. Patients with any additional concomitant surgical procedures were excluded.
Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \<20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI \>40 kg/m2).
The primary endpoint was long-term mortality. The secondary end-point was the rate of sternal wound infections.
Summary statistics were calculated. Continuous data are described as the median, with the interquartile range in parentheses, while categorical data are shown as numbers with percentages. Differences between groups for normally distributed, continuous variables were determined using the one-way analysis of variance with Holm-Sidak post-hoc test. The Kruskal Wallis test was used for the analysis of non-normally distributed continuous variables with Dunn's test for post hoc comparison. The chi-squared test was used for the analysis of categorical variables. Bonferoni's correction was used for post-hoc analysis. The univariable analysis was performed using logistic regression. For multivariable analysis a logistic regression model was performed, with mortality or wound infection as the dependent variable, and all other characteristics summarized in the table 1 as independent variables. The backward conditional selection was used for modeling with variables with score statistics \<0.1 included in the model. Significance was assessed at p\<0.05. Multiple imputation was not used to adjust for missing data. The number of valid entries for each variable and alterations in the sample size for specific analyses are described.
Analyses were performed using IBM SPSS Version 22.0 and MedCalc Version 19.4.1.
- Conditions
- Obesity, Coronary Artery Disease, Angina Pectoris, Coronary; Ischemic
- Being tested
- coronary artery bypass grafting
- Keywords
- body mass index, coronary artery bypass grafting, obesity, mortality
- Medical subject headings
- Obesity, Coronary Artery Disease, Angina Pectoris, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass graftingProcedure or surgery
surgical coronary revascularization
| Study group | Role | What they receive |
|---|---|---|
| underweight | BMI <20.0 kg/m2 Receives: Procedure: coronary artery bypass grafting | |
| normal weight | BMI 20.0-24.9 kg/m2 Receives: Procedure: coronary artery bypass grafting | |
| overweight | BMI 25-29.9 kg/m2 Receives: Procedure: coronary artery bypass grafting | |
| obesity class I | BMI 30-34.9 kg/m2 Receives: Procedure: coronary artery bypass grafting | |
| obesity class II | BMI 35-39.9 kg/m2 Receives: Procedure: coronary artery bypass grafting | |
| obesity class III | BMI >40 kg/m2 Receives: Procedure: coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term mortality
Measured: 2014-2022
Secondary outcomes (1)
sternal wound infection rate
Measured: 2014-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Jan 2014
- Primary completion30 Sep 2020
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614023
- Sponsor's protocol ID
- BNW-1-065/N/3/K
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Body Mass Index on Mortality in Patients Undergoing Coronary Artery Bypass Grafting: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06614023
- Acronym / sponsor ID
- BNW-1-065/N/3/K
- Conditions
- Obesity, Coronary Artery Disease, Angina Pectoris, Coronary; Ischemic
- Keywords
- body mass index, coronary artery bypass grafting, obesity, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,448 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jan 2014
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All consecutive patients who underwent isolated coronary artery bypass grafting (CABG) at our institution from 2014 to 2020 were included. Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \<20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI \>40 kg/m2). The long-term mortality was analyzed as primary end-point. The univariable and multivariable analysis was performed using logistic regression modeling.
Detailed description
All consecutive patients aged above eighteen who underwent isolated CABG were enrolled. Patients operated on- and off-pump were included. We reviewed elective, urgent, emergency and salvage surgeries. Patients with any additional concomitant surgical procedures were excluded.
Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \<20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI \>40 kg/m2).
The primary endpoint was long-term mortality. The secondary end-point was the rate of sternal wound infections.
Summary statistics were calculated. Continuous data are described as the median, with the interquartile range in parentheses, while categorical data are shown as numbers with percentages. Differences between groups for normally distributed, continuous variables were determined using the one-way analysis of variance with Holm-Sidak post-hoc test. The Kruskal Wallis test was used for the analysis of non-normally distributed continuous variables with Dunn's test for post hoc comparison. The chi-squared test was used for the analysis of categorical variables. Bonferoni's correction was used for post-hoc analysis. The univariable analysis was performed using logistic regression. For multivariable analysis a logistic regression model was performed, with mortality or wound infection as the dependent variable, and all other characteristics summarized in the table 1 as independent variables. The backward conditional selection was used for modeling with variables with score statistics \<0.1 included in the model. Significance was assessed at p\<0.05. Multiple imputation was not used to adjust for missing data. The number of valid entries for each variable and alterations in the sample size for specific analyses are described.
Analyses were performed using IBM SPSS Version 22.0 and MedCalc Version 19.4.1.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| underweight | – | Procedure: coronary artery bypass graftingBMI <20.0 kg/m2 |
| normal weight | – | Procedure: coronary artery bypass graftingBMI 20.0-24.9 kg/m2 |
| overweight | – | Procedure: coronary artery bypass graftingBMI 25-29.9 kg/m2 |
| obesity class I | – | Procedure: coronary artery bypass graftingBMI 30-34.9 kg/m2 |
| obesity class II | – | Procedure: coronary artery bypass graftingBMI 35-39.9 kg/m2 |
| obesity class III | – | Procedure: coronary artery bypass graftingBMI >40 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients undergoing isolated CABG
Key inclusion criteria (1 listed)
- patients undergoing isolated CABG
Key exclusion criteria (1 listed)
- any concomitant additional surgical procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery bypass graftingsurgical coronary revascularization | Procedure or surgery | normal weight, obesity class I, obesity class II, obesity class III, overweight, underweight |
Primary outcome
long-term mortality
Time frame: 2014-2022
1 secondary outcome
sternal wound infection rate
Time frame: 2014-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Coronary Artery Disease, run by Medical University of Silesia.
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: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term mortality (time frame: 2014-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2024.