Andrey Pryakhin
Tomsk, Tomsk State, 634012, Russia
NCT Number: NCT04916912
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.
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Notify Me18 year–75 year
All sexes
Observational
Tomsk, Tomsk State, 634012, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Coronary artery bypass surgery is a surgical procedure to restore normal blood flow to an obstructed or stenotic coronary artery.
Other names: CABG
Time frame: 30 days
In-hospital mortality rate (%)
Time frame: 30 days
neurological injury (TIA, stroke, delirium)
Time frame: 30 days
creatinine level prior and 1 postoperative day, urine output-up to 24-48 h, renal replacement therapy
Time frame: 30 days
Duration of mechanical ventilation
Time frame: 30 days
re-exploration for bleeding, tamponade or other reasons
Time frame: 30 days
packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate
Time frame: 30 days
postoperative myocardial infarction (electrocardiogram and troponins)
Time frame: 48 hours
inotropic support during 24-48 h postoperatively
Time frame: 30 days
length of stay (intensive care unit and total hospital days).
Tomsk National Research Medical Center of the Russian Academy of Sciences
Other
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