Nctid:
NCT06614023
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003324", "term"=>"Coronary Artery Disease"}, {"id"=>"D000787", "term"=>"Angina Pectoris"}], "ancestors"=>[{"id"=>"D003327", "term"=>"Coronary Disease"}, {"id"=>"D017202", "term"=>"Myocardial Ischemia"}, {"id"=>"D006331", "term"=>"Heart Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D001161", "term"=>"Arteriosclerosis"}, {"id"=>"D001157", "term"=>"Arterial Occlusive Diseases"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002637", "term"=>"Chest Pain"}, {"id"=>"D010146", "term"=>"Pain"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M6549", "name"=>"Coronary Disease", "relevance"=>"LOW"}, {"id"=>"M6546", "name"=>"Coronary Artery Disease", "asFound"=>"Coronary Artery Disease", "relevance"=>"HIGH"}, {"id"=>"M19506", "name"=>"Myocardial Ischemia", "relevance"=>"LOW"}, {"id"=>"M4117", "name"=>"Angina Pectoris", "asFound"=>"Angina Pectoris", "relevance"=>"HIGH"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"M4469", "name"=>"Arteriosclerosis", "relevance"=>"LOW"}, {"id"=>"M4465", "name"=>"Arterial Occlusive Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M5882", "name"=>"Chest Pain", "relevance"=>"LOW"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>6448}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2014-01-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2022-02-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-02", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2020-09-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"long-term mortality", "timeFrame"=>"2014-2022"}], "secondaryOutcomes"=>[{"measure"=>"sternal wound infection rate", "timeFrame"=>"2014-2022"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["body mass index", "coronary artery bypass grafting", "obesity", "mortality"], "conditions"=>["Obesity", "Coronary Artery Disease", "Angina Pectoris", "Coronary; Ischemic"]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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.\n\nPatients 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).\n\nThe primary endpoint was long-term mortality. The secondary end-point was the rate of sternal wound infections.\n\nSummary 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.\n\nAnalyses were performed using IBM SPSS Version 22.0 and MedCalc Version 19.4.1."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"all consecutive patients undergoing isolated CABG", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* patients undergoing isolated CABG\n\nExclusion Criteria:\n\nany concomitant additional surgical procedures"}, "identificationModule"=>{"nctId"=>"NCT06614023", "briefTitle"=>"Impact of Body Weight on Outcomes of Patients Undergoing Coronary Artery Bypass Grafting", "organization"=>{"class"=>"OTHER", "fullName"=>"Medical University of Silesia"}, "officialTitle"=>"Impact of Body Mass Index on Mortality in Patients Undergoing Coronary Artery Bypass Grafting: a Retrospective Cohort Study", "orgStudyIdInfo"=>{"id"=>"BNW-1-065/N/3/K"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"underweight", "description"=>"BMI \\<20.0 kg/m2", "interventionNames"=>["Procedure: coronary artery bypass grafting"]}, {"label"=>"normal weight", "description"=>"BMI 20.0-24.9 kg/m2", "interventionNames"=>["Procedure: coronary artery bypass grafting"]}, {"label"=>"overweight", "description"=>"BMI 25-29.9 kg/m2", "interventionNames"=>["Procedure: coronary artery bypass grafting"]}, {"label"=>"obesity class I", "description"=>"BMI 30-34.9 kg/m2", "interventionNames"=>["Procedure: coronary artery bypass grafting"]}, {"label"=>"obesity class II", "description"=>"BMI 35-39.9 kg/m2", "interventionNames"=>["Procedure: coronary artery bypass grafting"]}, {"label"=>"obesity class III", "description"=>"BMI \\>40 kg/m2", "interventionNames"=>["Procedure: coronary artery bypass grafting"]}], "interventions"=>[{"name"=>"coronary artery bypass grafting", "type"=>"PROCEDURE", "description"=>"surgical coronary revascularization", "armGroupLabels"=>["normal weight", "obesity class I", "obesity class II", "obesity class III", "overweight", "underweight"]}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Medical University of Silesia", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
