Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker : a Korean Nationwide Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Composite of Outcomes
研究概览
简要总结
In this study, the investigators evaluated the association between various measures of adiposity [BMI and waist circumference (WC)] and clinical outcomes in Asian patients who underwent pacemaker insertion, using a nationwide population based cohort.
详细描述
This retrospective nationwide cohort study used administrative claims data from the Korean National Health Insurance Service (NHIS) and the combined health check-up database of the National Health Insurance Corporation between 2013 and 2020.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who underwent pacemaker insertion between January 2015 and December 2020
排除标准
- •Patients aged <20 years
- •Patients already taken pacemaker insertion before 2015
- •Patients with cancer
结局指标
主要结局
Composite of Outcomes
时间窗: 5 years
Death + CV hospitalization + Fatal arrest event + Infective endocarditis
次要结局
- Infective endocarditis(5 years)
- Death(5 years)
- Fatal arrest event(5 years)
- CV hospitalization(5 years)
研究者
Kwang-No Lee
Professor
Ajou University School of Medicine
