Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Atrial fibrilation (AF / atrial flutter)
研究概览
简要总结
The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.
详细描述
The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to understand the nature of study and has provided written informed consent.
- •Patient with Acute Coronary Syndrome, with or without elevation of the ST segment at the EKG (the last with elevation of troponins).
- •Patient with coronariography at the episode of ACS showing severe lesions treated with stent.
- •Patient with risk index for 6-month mortality (GRACE score) of more than
- •Patient with risk index for stroke (CHA2DS2-VACS score) of more than 2.
排除标准
- •Patient with history of AF.
- •Patient with episodes of AF during admission at the current episode.
- •Patient with pacemaker or ICD (implantable cardioverter-defibrillator) previously.
- •Patient with indication of pacemaker or ICD in current or short-term phase.
- •Patient is participating in another interventional clinical investigation.
- •Patient is pregnant or breast feeding.
- •Patient´s life-expectancy is less than 24 months.
结局指标
主要结局
Atrial fibrilation (AF / atrial flutter)
时间窗: 1 year
Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.
Ventricular arrhythmia in the electrocardiogram (EKG)
时间窗: 1 year
Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.
Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG
时间窗: 1 year
Detection rates of advanced conduction abnormalities and significant ST shifts (\> 1 mm) in the EKG.
次要结局
- Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile(1 year)
- Re-hospitalization(1 year)
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(1 year)