Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker
NCT ID: NCT05645978
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20000 participants
OBSERVATIONAL
2022-07-01
2024-12-31
Brief Summary
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Detailed Description
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The investigators included patients who underwent pacemaker insertion between January 2015 and December 2020. Patients aged \<20 years, those who were already taken pacemaker insertion 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 device procedure) 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 who underwent pacemaker insertion during study period
Patients who underwent pacemaker insertion between January 2015 and December 2020
Pacemaker insertion
Patients who underwent pacemaker insertion between January 2015 and December 2020
Interventions
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Pacemaker insertion
Patients who underwent pacemaker insertion between January 2015 and December 2020
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients already taken pacemaker insertion 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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Central Contacts
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References
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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.
Prasitlumkum N, Chokesuwattanaskul R, Kaewput W, Thongprayoon C, Bathini T, Boonpheng B, Vallabhajosyula S, Cheungpasitporn W, Jongnarangsin K. Utilization and in-hospital complications of catheter ablation for atrial fibrillation in patients with obesity and morbid obesity. Clin Cardiol. 2022 Apr;45(4):407-416. doi: 10.1002/clc.23795. Epub 2022 Feb 16.
Seo J, Li W, Safiriyu I, Kharawala A, Nagraj S, Tahir A, Doundoulakis I, Koliastasis L, Rios S, Palaiodimos L, Kokkinidis DG. A Meta-Analysis on the Impact of High BMI in Patients Undergoing Transcatheter Aortic Valve Replacement. J Cardiovasc Dev Dis. 2022 Nov 9;9(11):386. doi: 10.3390/jcdd9110386.
Other Identifiers
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AJOUIRB-EXP-2021-398-6
Identifier Type: -
Identifier Source: org_study_id
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