Association of Obesity and Cardiovascular Outcomes in Myocardial Infarction
NCT ID: NCT05645926
Last Updated: 2023-07-27
Study Results
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Basic Information
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UNKNOWN
60000 participants
OBSERVATIONAL
2022-07-01
2024-12-31
Brief Summary
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Detailed Description
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The investigators included patients newly diagnosed with MI and underwent revascularization (PCI or CABG) between January 2015 and December 2020. Patients aged \<20 years, those who were already diagnosed with MI before 2015, and those with cancer were excluded from the analysis. The follow-up period was defined as the time from the index date (date of diagnosis) to each outcome event, date of death, or end of the study period (December 31, 2020), whichever came first.
Patients' demographic data, comorbidities, concomitant medications, and income level were collected from the Korean NHIS database. The recent health check-up data from the index date was also ascertained, including height, weight, waist circumference, blood pressure, health surveys, and laboratory exam. Health survey included family history, smoking history, alcohol history, and the level of individual physical activity.
According to BMI following the World Health Organization recommendation for Asian population, study patients were categorized into 5 groups: underweight, \<18.5 kg/m2; normal range, 18.5 to \<23 kg/m2; overweight, 23 to \<25 kg/m2; obese I, 25 to \<30 kg/m2; and obese II, ≥30 kg/m2\[4\]. The investigators defined the proportion of medical use by calculating formula with the recuperation cost and the number of the visit to hospitals.
During the follow-up period, The investigators assessed 3 clinical outcomes, including all-cause death, cardiovascular hospitalization and the recurrence rate. Clinical outcomes were mainly defined by the the International Classification of Diseases, 10th revision (ICD-10). Patients were censored at the clinical outcomes or the end of the study period (December 31, 2020), whichever came first.
All categorical variables are presented as frequencies and percentages. Normally distributed data were presented as mean ± standard deviation, whereas nonparametric data are presented as median and interquartile range by BMI.
Cox proportional hazard regression analyses were performed to identify the association of BMI with the primary and secondary outcomes, calculating hazard ratio (HR) and 95% confidence interval (CI) and adjusting for the following potential confounders: sex, age, systolic blood pressure, fasting glucose level, total cholesterol level, alcohol consumption, smoking status, physical activity, household income, use of antihypertensive agents, use of statins, use of antiplatelet agents, previous history of MI, previous history of stroke, and index year. All analyses were conducted using R-statistics.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients with MI who underwent revascularization during study period
Patients newly diagnosed with MI and underwent revascularization (PCI or CABG) during study period
Percutaneous coronary intervention (PCI)
Patients who underwent percutaneous coronary intervention (PCI), including percutaneous transluminal coronary angioplasty (PTCA), and coronary stent insertion
Coronary artery bypass grafting (CABG)
Patients who underwent coronary artery bypass grafting (CABG)
Interventions
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Percutaneous coronary intervention (PCI)
Patients who underwent percutaneous coronary intervention (PCI), including percutaneous transluminal coronary angioplasty (PTCA), and coronary stent insertion
Coronary artery bypass grafting (CABG)
Patients who underwent coronary artery bypass grafting (CABG)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients diagnosed with MI before 2015
* Patients with cancer
20 Years
ALL
Yes
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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Kwang-No Lee
Professor
Principal Investigators
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Kwang-No LEE
Role: STUDY_CHAIR
Ajou University School of Medicine
Locations
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Ajou University School of Medicine
Suwon, Gyeonggi-do, South Korea
Countries
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References
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Park SJ, Ha KH, Kim DJ. Body mass index and cardiovascular outcomes in patients with acute coronary syndrome by diabetes status: the obesity paradox in a Korean national cohort study. Cardiovasc Diabetol. 2020 Nov 10;19(1):191. doi: 10.1186/s12933-020-01170-w.
Kim MS, Kim WJ, Khera AV, Kim JY, Yon DK, Lee SW, Shin JI, Won HH. Association between adiposity and cardiovascular outcomes: an umbrella review and meta-analysis of observational and Mendelian randomization studies. Eur Heart J. 2021 Sep 7;42(34):3388-3403. doi: 10.1093/eurheartj/ehab454.
Biswas S, Andrianopoulos N, Dinh D, Duffy SJ, Lefkovits J, Brennan A, Noaman S, Ajani A, Clark DJ, Freeman M, Oqueli E, Hiew C, Reid CM, Stub D, Chan W. Association of Body Mass Index and Extreme Obesity With Long-Term Outcomes Following Percutaneous Coronary Intervention. J Am Heart Assoc. 2019 Nov 5;8(21):e012860. doi: 10.1161/JAHA.119.012860. Epub 2019 Oct 25.
Other Identifiers
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AJOUIRB-EXP-2021-398-2
Identifier Type: -
Identifier Source: org_study_id
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