Chronic Ischemic Heart DiseaseNCT04916912
Results of Coronary Artery Bypass Grafting in Obese Patients
An observational study of Chronic Ischemic Heart Disease and Obesity, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Ischemic Heart Disease, Obesity
- What is being tested?
- coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2020to 1 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being living in Russian Federation (inc. ethnic minorities) with chronic ischemic heart disease and indications for cardiac surgery
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
It is planned to retrospectively enroll around 500 patients who underwent coronary artery bypass grafting for chronic ischemic heart disease at the Tomsk Research Institute of Cardiology. It is planned to develop a register of isolated coronary bypass grafting procedures, to conduct a comparative analysis of hospital results in obese patients (BMI more than 30 kg / m2) and without (BMI less than 30 kg / m2), to identify risk factors for adverse outcomes in patients of this group of patients.
Planning methods:
- Clinical status of the patient: collection of complaints, medical history, physical examination, assessment of anthropometric indicators (measurement of body weight, height, BMI), and demographic indicators before and in the control period after surgical treatment.
- General clinical examination: standard 12-lead ECG, general urine analysis, general blood analysis, blood chemistry, coagulation, chest x-ray, ultrasound of the carotid and femoral arteries.
- Coronarography to assess the anatomy and condition of the coronary arteries.
- Echocardiography to assess the following parameters: mass of viable left ventricular myocardium; volumes of cardiac cavities; diameter of the mitral and tricuspid valve rings with the determination of regurgitation degree; the long axis of the ventricle; left ventricular ejection fraction; visualization of akinetic and hypokinetic myocardium; the presence of blood clots in the cavities of the heart; All surgical procedures will be performed via median sternotomy Intraoperative information will be collected from the anesthetic record, surgical notes and perfusion records. Intraoperative data collection will include total operative time, CPB time, cross-clamp time, intraoperative red blood cell transfusion (units), highest dose/agent used for intraoperative inotrope or vasopressor support. Intraoperative flowmetry of coronary grafts during coronary artery bypass grafting using the Medistim VeriQ System will be performed.
Postoperative data will include valuation of following indicators: mortality (hospital mortality and death from any cause); neurological injury (TIA, stroke, delirium), acute kidney injury (creatinine level prior and 1 postoperative day, urine output-up to 24-48 h, renal replacement therapy (dialysis); time of mechanical ventilation; re-exploration for bleeding, tamponade or other reasons; postoperative transfusion (packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate); postoperative myocardial infarction (electrocardiogram and troponins); inotropic support during 24-48 h (agent and dose (VIS)); length of stay (intensive care unit and total hospital days).
Structured collection of patient data will be performed in a database formed on the platform of the Microsoft Excel 2010 software (Microsoft Corp., USA). Statistical processing of the results will be carried out using the SPSS 23.0 for Windows software package (IBM Corp., Armonk, NY, USA). The normality of the law of distribution of quantitative indicators will be checked using the Shapiro-Wilks criterion. Normally distributed parameters will be presented as mean value (M) and standard deviation (StD) in the form M ± StD; not normally distributed parameters will be presented as median (Me) and the 1st and 3rd interquantile intervals (Q25 - Q75) in the form of Me [Q25; Q75]. Qualitative data will be described by the frequency of occurrence or its percentage. To find statistical dependences, to determine their strength and direction, the Pearson correlation coefficient (r) (for normally distributed parameters) and Spearman correlation coefficient (for for not normally distributed parameters and for qualitative indicators in the ordinal scale) will be calculated. Using logistic regression, significant predictors will be identified for the values of reverse remodeling in the long term after surgical treatment. When conducting a multivariate analysis of interconnections, first, by means of a univariate analysis, the main parameters that influence the studied value will be identified, then, based on the search for intergroup correlations, the signs that have a moderate or strong relationship will be eliminated, and multivariate modeling of the relationships will be performed.
During the work, the methods of statistical analysis can be revised and (or) supplemented.
- Conditions
- Chronic Ischemic Heart Disease, Obesity
- Being tested
- coronary artery bypass grafting
- Keywords
- Chronic Ischemic Heart Disease, Obesity, coronary artery bypass grafting
- Medical subject headings
- Obesity
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
Also called CABG
Coronary artery bypass surgery is a surgical procedure to restore normal blood flow to an obstructed or stenotic coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
In-hospital mortality rate (%)
Measured: 30 days
Secondary outcomes (8)
neurological injury
neurological injury (TIA, stroke, delirium)
Measured: 30 days
acute kidney injury
creatinine level prior and 1 postoperative day, urine output-up to 24-48 h, renal replacement therapy
Measured: 30 days
Duration of mechanical ventilation
Duration of mechanical ventilation
Measured: 30 days
re-exploration
re-exploration for bleeding, tamponade or other reasons
Measured: 30 days
postoperative transfusion
packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate
Measured: 30 days
postoperative myocardial infarction
postoperative myocardial infarction (electrocardiogram and troponins)
Measured: 30 days
Duration of inotropic support
inotropic support during 24-48 h postoperatively
Measured: 48 hours
length of stay
length of stay (intensive care unit and total hospital days).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 May 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic Heart DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey S Pryakhin, PhD, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916912
- Sponsor's protocol ID
- CRI-03NR
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Coronary Artery Bypass Grafting in Obese Patients
- ClinicalTrials.gov ID
- NCT04916912
- Acronym / sponsor ID
- CRI-03NR
- Conditions
- Chronic Ischemic Heart Disease, Obesity
- Keywords
- Chronic Ischemic Heart Disease, Obesity, coronary artery bypass grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 8 Jun 2021 (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.
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.
Detailed description
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.
It is planned to retrospectively enroll around 500 patients who underwent coronary artery bypass grafting for chronic ischemic heart disease at the Tomsk Research Institute of Cardiology. It is planned to develop a register of isolated coronary bypass grafting procedures, to conduct a comparative analysis of hospital results in obese patients (BMI more than 30 kg / m2) and without (BMI less than 30 kg / m2), to identify risk factors for adverse outcomes in patients of this group of patients.
Planning methods:
- Clinical status of the patient: collection of complaints, medical history, physical examination, assessment of anthropometric indicators (measurement of body weight, height, BMI), and demographic indicators before and in the control period after surgical treatment.
- General clinical examination: standard 12-lead ECG, general urine analysis, general blood analysis, blood chemistry, coagulation, chest x-ray, ultrasound of the carotid and femoral arteries.
- Coronarography to assess the anatomy and condition of the coronary arteries.
- Echocardiography to assess the following parameters: mass of viable left ventricular myocardium; volumes of cardiac cavities; diameter of the mitral and tricuspid valve rings with the determination of regurgitation degree; the long axis of the ventricle; left ventricular ejection fraction; visualization of akinetic and hypokinetic myocardium; the presence of blood clots in the cavities of the heart; All surgical procedures will be performed via median sternotomy Intraoperative information will be collected from the anesthetic record, surgical notes and perfusion records. Intraoperative data collection will include total operative time, CPB time, cross-clamp time, intraoperative red blood cell transfusion (units), highest dose/agent used for intraoperative inotrope or vasopressor support. Intraoperative flowmetry of coronary grafts during coronary artery bypass grafting using the Medistim VeriQ System will be performed.
Postoperative data will include valuation of following indicators: mortality (hospital mortality and death from any cause); neurological injury (TIA, stroke, delirium), acute kidney injury (creatinine level prior and 1 postoperative day, urine output-up to 24-48 h, renal replacement therapy (dialysis); time of mechanical ventilation; re-exploration for bleeding, tamponade or other reasons; postoperative transfusion (packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate); postoperative myocardial infarction (electrocardiogram and troponins); inotropic support during 24-48 h (agent and dose (VIS)); length of stay (intensive care unit and total hospital days).
Structured collection of patient data will be performed in a database formed on the platform of the Microsoft Excel 2010 software (Microsoft Corp., USA). Statistical processing of the results will be carried out using the SPSS 23.0 for Windows software package (IBM Corp., Armonk, NY, USA). The normality of the law of distribution of quantitative indicators will be checked using the Shapiro-Wilks criterion. Normally distributed parameters will be presented as mean value (M) and standard deviation (StD) in the form M ± StD; not normally distributed parameters will be presented as median (Me) and the 1st and 3rd interquantile intervals (Q25 - Q75) in the form of Me [Q25; Q75]. Qualitative data will be described by the frequency of occurrence or its percentage. To find statistical dependences, to determine their strength and direction, the Pearson correlation coefficient (r) (for normally distributed parameters) and Spearman correlation coefficient (for for not normally distributed parameters and for qualitative indicators in the ordinal scale) will be calculated. Using logistic regression, significant predictors will be identified for the values of reverse remodeling in the long term after surgical treatment. When conducting a multivariate analysis of interconnections, first, by means of a univariate analysis, the main parameters that influence the studied value will be identified, then, based on the search for intergroup correlations, the signs that have a moderate or strong relationship will be eliminated, and multivariate modeling of the relationships will be performed.
During the work, the methods of statistical analysis can be revised and (or) supplemented.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG-1 | – | Procedure: coronary artery bypass graftingA 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 | – | Procedure: coronary artery bypass graftingA group of obese patients (BMI over 30 kg / m2) who underwent isolated coronary artery bypass grafting for chronic ischemic heart disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being living in Russian Federation (inc. ethnic minorities) with chronic ischemic heart disease and indications for cardiac surgery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
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 graftingAlso: CABGCoronary artery bypass surgery is a surgical procedure to restore normal blood flow to an obstructed or stenotic coronary artery. | Procedure or surgery | CABG-1, CABG-2 |
Primary outcome
Death
Time frame: 30 days
In-hospital mortality rate (%)
8 secondary outcomes
neurological injury
Time frame: 30 days
acute kidney injury
Time frame: 30 days
Duration of mechanical ventilation
Time frame: 30 days
re-exploration
Time frame: 30 days
postoperative transfusion
Time frame: 30 days
postoperative myocardial infarction
Time frame: 30 days
Duration of inotropic support
Time frame: 48 hours
length of stay
Time frame: 30 days
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 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Andrey S Pryakhin, PhD principal investigator
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ischemic Heart Disease and Obesity, run by Tomsk National Research Medical Center of the Russian Academy of Sciences 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 3 inclusion and 8 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 24 Jun 2026. 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?
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?
Death (time frame: 30 days). 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 24 Jun 2026.