跳至主要内容
临床试验/NCT04456842
NCT04456842已完成不适用

Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study

Brazilian Clinical Research Institute17 个研究点 分布在 4 个国家目标入组 2,016 人开始时间: 2020年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,016
试验地点
17
主要终点
Percentage of electrical cardioversion

研究概览

简要总结

Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death

详细描述

Patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.

研究设计

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

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

  • Age > 18 years-old that signed informed consent;
  • Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source document;
  • If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h);

排除标准

  • Patients who did not agree to participate.
  • Patients without possibility of monitoring for one year.

结局指标

主要结局

Percentage of electrical cardioversion

时间窗: 12 months

INR control rate

时间窗: 12 months

Oral anticoagulation discontinuation rate

时间窗: 12 months

Percentage of systemic embolism

时间窗: 12 months

Percentage of other cardiovascular hospitalization

时间窗: 12 months

Percentage of major bleeding

时间窗: 12 months

Percentage of atrioventricular junction ablation

时间窗: 12 months

Percentage of patients that need of pacemaker implantation

时间窗: 12 monts

Percentage of death

时间窗: 12 months

Percentage of stroke

时间窗: 12 months

Percentage of myocardial infarction

时间窗: 12 months

Percentage of percutaneous ablation of AF

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Brazilian Clinical Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (17)

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