Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Incidence of new-onset AF at 30-days post-MI
研究概览
简要总结
After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST) have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR), although the routine implantation of ILRs post-MI remains costly and invasive. The external loop recorder may effectively identify patients with new-onset AF through a validated diagnostic algorithm and targeted monitoring during a high-risk period (immediately after hospital discharge). We will prospectively randomize patients to receive an external loop recorder or standard care, evaluating rates of new-onset AF developing within 30 days after MI.
详细描述
The SIMPL-AF trial will evaluate the role of intensive monitoring after myocardial infarction, assessing for new-onset AF after hospital discharge. Patients will be randomized to receive intensive monitoring or standard care in a 2:1 distribution. Patients randomized to intensive monitoring will receive a SpiderFlash® monitor, worn for 30-days after discharge and returned for analysis.
The primary objective of this study is to evaluate at the incidence of new-onset AF at 30-days post-MI using an intensive monitoring strategy, compared to standard of care. Secondary objectives include the impact of intensive monitoring on oral anticoagulation rates at 90-days and 1-year after monitoring, and the risk factors for developing new-onset AF, and the variables associated with initiating or withholding anticoagulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI; Third Universal Definition of MI) with or without PCI. All patients must have troponin elevation.
- •No history of AF during hospitalization, at discharge, or pre-existing AF documented on history (i.e. hospital records, previous hospitalization, ECG records).
- •No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, venous thromboembolism/deep venous thrombosis).
- •No concomitant disease expected to reduce expected lifespan to <2 yrs.
排除标准
- •Patients receiving CABG surgery during this hospitalization or planned cardiac surgery within the next 3 months.
- •Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic coronary disease (NACAD), and Takotsubo cardiomyopathy are excluded from this study.
- •Patients with contraindications to anticoagulation.
- •Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape or glue.
结局指标
主要结局
Incidence of new-onset AF at 30-days post-MI
时间窗: 30 days
New-onset AF detected through intensive monitoring or standard care (routine assessment)
次要结局
- Rate of oral anticoagulation(90 days and 1-year)
- AF-related hospitalization(90 days and 1-year)
- Composite cardiovascular and hospitalization events(90 days and 1-year)
研究者
Jason Andrade
Principal Investigator
University of British Columbia