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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary artery bypass grafting | Procedure | Coronary artery bypass surgery is a surgical procedure to restore normal blood flow to an obstructed or stenotic coronary artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death | In-hospital mortality rate (%) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| neurological injury | neurological injury (TIA, stroke, delirium) | 30 days |
| acute kidney injury | creatinine level prior and 1 postoperative day, urine output-up to 24-48 h, renal replacement therapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being living in Russian Federation (inc. ethnic minorities) with chronic ischemic heart disease and indications for cardiac surgery
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| Name | Affiliation | Role |
|---|---|---|
| Andrey S Pryakhin, PhD | Tomsk NRMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrey Pryakhin | Tomsk | Tomsk State | 634012 | Russia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 30 days |
| Duration of mechanical ventilation | Duration of mechanical ventilation | 30 days |
| re-exploration | re-exploration for bleeding, tamponade or other reasons | 30 days |
| postoperative transfusion | packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate | 30 days |
| postoperative myocardial infarction | postoperative myocardial infarction (electrocardiogram and troponins) | 30 days |
| Duration of inotropic support | inotropic support during 24-48 h postoperatively | 48 hours |
| length of stay | length of stay (intensive care unit and total hospital days). | 30 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |