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临床试验/NCT01380574
NCT01380574已完成不适用

Safety of Cardioversion of Acute Atrial Fibrillation

Turku University Hospital3 个研究点 分布在 1 个国家目标入组 7,700 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7,700
试验地点
3
主要终点
Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF

研究概览

简要总结

The purpose of this study is to investigate the complications of cardioversion of acute (<48 hours duration) atrial fibrillation (AF).

Primary Outcome Measures:

  • Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF

Secondary Outcome Measures:

  • Number of therapy non-responder and early recurrence of AF
  • Bleeding complications during the 31 days follow-up
  • Hemodynamic complications of cardioversion

Estimated Enrollment: 3000 cases

Study Start Date: Jun 2011

Estimated Study Completion Date: December 2011

详细描述

It has been a common practice to perform cardioversion of acute (<48 hour) AF without any anticoagulation. The new European guidelines recommend that anticoagulation should be started already before cardioversion in all patients with CHADS2VASC score indicating need for long-term oral anticoagulation. The evidence behind these guidelines is, however, scarce. In this retrospective study we collect data on the safety of acute AF cardioversion from emergency rooms of two university hospitals and one secondary referral center from the years 2003-2010.

Inclusion criteria:

All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms

排除标准

  • duration of the AF is unknown or >48 hours

结局指标

主要结局

Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF

时间窗: 31 days

次要结局

  • Bleeding complications during the 31 days follow-up(31 days)
  • Hemodynamic complications of cardioversion(31 days)
  • Number of therapy non-responder and early recurrence of AF(31 days)

研究者

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

Juhani Airaksinen

Professor

Turku University Hospital

研究点 (3)

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