跳至主要内容
临床试验/NCT06802965
NCT06802965Enrolling By Invitation不适用

Shanghai Atrial Fibrillation Registry

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 400,000 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400,000
试验地点
1
主要终点
Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure

研究概览

简要总结

Using the Shanghai Municipal Health Commission database and Shanghai Centers for Disease Control and Prevention database, patients with AF in Shanghai are included to construct the Shanghai AF registry to investigate clinical characteristics, treatment, and prognosis.

详细描述

  1. To determine the most suitable risk stratification model for Chinese AF population regarding stroke and major cardiovascular events, i.e. CHA2DS2-VASc, CHA2DS2-VASc-60, or CHA2DS2-VA scores.
  2. To compare the clinical prognosis of patients with AF receiving the combined procedure of catheter ablation and left atrial appendage closure (LAAC), single catheter ablation, and single LAAC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • With diagnosis of AF: the diagnosis must be identified from the Shanghai Municipal Health Commission database and verified by 12-lead ECG or Holter monitoring since 2015
  • Residents of Shanghai
  • Taking part in the government-issued health insurance, including the Urban Residents' Basic Medical Insurance (URBMI), the Urban-Employ Based Medical Insurance (UEBMI) and the New Rural Cooperative Medical Scheme (NRCMS).

排除标准

  • Non-residence of Shanghai
  • Without the government-issued health insurance
  • Die at the day of index diagnosis of AF

结局指标

主要结局

Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure

时间窗: From enrollment to December 31, 2024

Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure

次要结局

  • Cardiovascular death(From enrollment to December 31, 2024)
  • Non-cardiovascular death(From enrollment to December 31, 2024)
  • Ischemic stroke(From enrollment to December 31, 2024)
  • Systemic embolism(From enrollment to December 31, 2024)
  • Myocardial infarction(From enrollment to December 31, 2024)
  • Major bleeding(From enrollment to December 31, 2024)
  • Acute Heart failure (HF)(From enrollment to December 31, 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yiguang LI

Dr

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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