National Tunisian Registry of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 910
- 试验地点
- 1
- 主要终点
- Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death
研究概览
简要总结
A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.
详细描述
The NATURE-AF study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. A total of 91 cardiologists participate in the selection of patients as investigators. The study is a longitudinal non-interventional registry of atrial fibrillation. The data collected are managed by the DACIMA Clinical Suite® platform, which complies with international standards: FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPPA (Health Insurance Portability and Accountability Act), ICH (International Conference on Harmonisation), MedDRA (Medical Dictionary for Regulatory Activities). The DACIMA Clinical Suite® platform allows to track the data entered, check for inconsistencies and missing data, and schedule monitoring visits. A Steering Committee is set up to monitor patient inclusions, verify data sources, perform audit trails and prepare the statistical analysis plan for the study.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one episode of atrial fibrillation, documented on a 12-lead ECG and / or a rhythmic holter (duration of the episode: 30 seconds or more)
- •Recent atrial fibrillation diagnosed for less than a year
- •Regular monitoring every 3 months is ensured
- •Informed, read and signed consent
排除标准
- •Estimated life expectancy at less than 12 months
- •Transient atrial fibrillation due to reversible cause (eg acute myocardial infarction, following cardiac surgery, acute alcohol intoxication, hyperthyroidism, pulmonary embolism or other acute pulmonary disease, pericarditis, myocarditis, hydro-electrolyte disorder, metabolic disorder)
- •Cardiac surgery ≤ 3 months
- •Atrial flutter isolated without atrial fibrillation
- •Mental disorders
- •Ongoing anticoagulation for reasons other than atrial fibrillation
结局指标
主要结局
Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death
时间窗: Every 3 months up to 1 year
Number of patients with ischemic stroke and/or transient ischemic attack, and/or arterial embolization during the follow-up period
次要结局
- Haemorrhagic accidents(Every 3 months up to 1 year)
- Measurement of INR (International Normalized Ratio)(Every month for 1 year)
- TTR (percent Time in Therapeutic INR Range)(1 year)