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临床试验/NCT05645913
NCT05645913进行中(未招募)不适用

Association of Obesity and Cardiovascular Outcomes in Patients With Atrial Fibrillation : a Korean Nationwide Cohort Study

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 56,272 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
56,272
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 with AF who were prescribed OAC, 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 oral anticoagulant (OAC) new users diagnosed with atrial fibrillation (AF) between January 2015 and December 2020. Patients aged <20 years, those who were regarded as valvular AF patients (patients with mitral stenosis or prosthetic heart valve), those with possible alternative indications for OAC (pulmonary embolism, deep vein thrombosis, or recent joint replacement surgery), and those with cancer were excluded from the analysis.

The follow-up period was defined as the time from the index date (date of OAC prescription) 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. The investigators defined the proportion of medical use by calculating formula with the recuperation cost and the number of the visit to hospitals.

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].

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

入选标准

  • Oral anticoagulant (OAC) new users diagnosed with atrial fibrillation (AF) between January 2015 and December 2020

排除标准

  • Patients aged <20 years
  • Valvular AF patients
  • Possible alternative indications for OAC (pulmonary embolism, deep vein thrombosis, or recent joint replacement surgery)
  • Cancer patients

研究组 & 干预措施

Atrial fibrillation with oral anticoagulant

patients who were newly receiving an oral anticoagulant for atrial fibrillation during study period

干预措施: Oral anticoagulant (Drug)

结局指标

主要结局

Composite of Outcomes

时间窗: 5 years

Thromboembolism+Bleeding+Death

次要结局

  • Thromboembolism(5 years)
  • Death(5 years)
  • Bleeding(5 years)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwang-No Lee

Professor

Ajou University School of Medicine

研究点 (1)

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