Registry of Atrial Fibrillation and Embolic Risk in Mexico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 主要终点
- Oral anticoagulation
研究概览
简要总结
The AF is the most common arrhythmia in clinical practice affecting 1-2% of the general population. It is the most common cause of cerebrovascular events (CVE), responsible for 25% of all ischemic strokes and 50% of cardioembolic strokes.
The CARMEN-AF registry is planned to be the first registry of non-valvular AF in Mexico with national representation, planning and specific objectives for publications. Follow-up period of two years is planned.
详细描述
The CARMEN-AF registry intends to achieve a national sample of non-valvular AF in male and female patients older than 18 years through the participation of every state of Mexico. Thus, a wide geographical distribution will allow comparing health care quality between different geographical areas in which the patients are attended (Northwest, North, Center, Mexico City, East and Southeast).
Besides, to guarantee this national representation, the principle health institutions are planned to participate, the public and the private ones.
Primary objectives:
To know the current state of thromboprophylaxis in non-valvular Atrial Fibrillation (AF) in Mexico.
To evaluate the therapeutic behavior according to the Clinical Practice Guidelines (CPG) at baseline and one year follow-up, with an educational strategy to increase the adherence.
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
- 否
入选标准
- •Patients with documented diagnosis of AF in the last six months by 12-lead electrocardiogram, rhythm strip, or Holter monitoring, pacemaker minimum 30 seconds (with or without treatment and regardless of rhythm during enrollment)
- •Patients presenting AF (diagnosed by standard ECG or Holter monitoring) at baseline
- •Patients should be eligible for treatment with oral anticoagulant thromboprophylaxis
- •Patients with at least 1 risk factor for thromboembolism (CVE or outside the CNS) according to CHA2DS2VASc
排除标准
- •AF of transient causes (thyrotoxicosis, alcohol intoxication, myocardial infarction (MI) acute phase, pericarditis, myocarditis, electrocution, pulmonary embolism or other lung disease, electrolyte or metabolic disorder,etc).
- •AF onset in immediate postoperative or 3 months in cardiac surgery
- •Terminal illness
- •Mental Inability to take anticoagulants
- •Inability to fulfill the follow-up visits
- •Programming for ablation of pulmonary veins
- •Pregnant or lactating women
结局指标
主要结局
Oral anticoagulation
时间窗: One year
To analyze quality of anticoagulation with vitamin K antagonists at baseline (control) and one year.
次要结局
未报告次要终点