A Prospective, Multi-Center, Randomized Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than or Equal to Eight Days Using MEMO Patch PLUS in Individuals Aged ≥ 75 Years, or Those at High Risk of Stroke: MEMO-DAF8
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of newly diagnosed AF
研究概览
简要总结
The purpose of this study is to evaluate the benefits in the atrial fibrillation detection rate of the continuous ECG monitoring group for more than 8 days by contrasting with one-day ECG monitoring using MEMO Patch PLUS in 1000 patients with atrial fibrillation-related symptoms in the high risk group of stroke. The participant is allocated randomly to One-day ECG monitoring group or the continuous ECG monitoring group for more than 8 days in ratio of 1:1, only if the participant provides informed consent and eligible for all the inclusion/exclusion criteria. The investigator confirms the results of MEMO Patch PLUS monitoring at 1 month from the date of MEMO Patch PLUS attachment. The participation of the subject is terminated on the 1 year from the date of MEMO Patch PLUS attachment. On that day, investigator evaluates incidence of the event associated with atrial fibrillation, the event is included ischemic stroke/transient ischemic accident, hemorrhagic stroke, systemic embolism, etc.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[Inclusion criteria]
- •A participant will be eligible for inclusion in the study if the participant:
- •Has provided documented informed consent for the study.
- •Is adult at least 19 years of age on the day of providing documented informed consent
- •Is the high risk group for stroke, i.e. adult at least 75 years of age or CHA2DS2-VASc score more than 2
- •Is life expectancy more than 6 months
- •Has no Atrial fibrillation or Atrial flutter as a result of 12-lead ECG
- •Has symptoms associated with Atrial fibrillation *symptoms associated with Atrial fibrillation: palpitation, dizziness, dyspnea, syncope, stroke/transient ischemic accident, systemic embolism etc.
排除标准
- •The participant must be excluded from the study if the participant:
- •Has had prior history of Atrial fibrillation or Atrial flutter
- •Has inserted Pacemaker or Defibrillator that can diagnose Atrial fibrillation or Atrial flutter
- •Has plan of Carotid endarterectomy or inserting Stent* within 90 days on the day of providing document informed consent *Stent insertion: means when stent-related interventions have been performed on the carotid arteyr or coronary arteries.
研究组 & 干预措施
MEMO Patch PLUS ECG monitoring for One-day
干预措施: MEMO Patch PLUS for 1 day (Device)
MEMO Patch PLUS ECG monitoring for More than 8-days
干预措施: MEMO Patch PLUS for More than 8-days (Device)
结局指标
主要结局
Incidence of newly diagnosed AF
时间窗: 2 month(±Month 2)
Incidence of newly diagnosed AF refers to a case that lasts longer than 30 seconds, which is an indication for anticoagulation or antiplatelet therapy in standard therapy.
次要结局
- Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.(1month(+1month), 12 month(±Month 2))
- Distribution rate of wearing period of ECG monitoring group for more than 8 days.(1month(+1month), 12 month(±Month 2))
- Time to the first occurrence of atrial fibrillation/flutter lasting more than 30 seconds after MEMO Patch PLUS is attached.(1month(+1month), 12 month(±Month 2))
- Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis.(1month(+1month), 12 month(±Month 2))
- Burden of total atrial fibrillation/flutter occurrence time(1month(+1month), 12 month(±Month 2))
- Incidence of significant medical events or death due to ischemic stroke/transient ischemic attack, systemic embolism, hemorrhagic stroke, atrial fibrillation/flutter.(1month(+1month), 12 month(±Month 2))
- Percentage of arrhythmias including atrial fibrillation/flutter were detected and surgery/procedure was performed for therapeutic or diagnostic purposes.(1month(+1month), 12 month(±Month 2))
- Detection rate of other arrhythmias* except atrial fibrillation/flutter.(1month(+1month), 12 month(±Month 2))