NCT03313167已完成不适用
Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,316 人开始时间: 2017年9月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,316
- 试验地点
- 1
- 主要终点
- number of subjects screened with AF not identified at Index Visit
研究概览
简要总结
To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 and one or more of the following: hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease
排除标准
- •Age < 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
number of subjects screened with AF not identified at Index Visit
时间窗: Up to 4 weeks from Index Visit
number of subjects screened who have AF not identified at their Index Visit but subsequently found to have AF confirmed by 12-lead Electrocardiogram (ECG) during the extended monitoring period
number of subjects screened with AF identified at Index Visit
时间窗: Up to 4 weeks
次要结局
- number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period(Day 1 up to week 24)
- number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period(Index Visit up to week 24)
- number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period(Day 1 up to week 24)
- number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy(24 week follow up period)
- number of subjects with AF identified at their Index Visit who are prescribed guideline recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up period(At week 24)
- number of subjects with PAF identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up(At week 24)
- number of subjects with ECG-confirmed AF detected by the Omron BP device(Day 1 to Day 14)
- number of subjects with ECG-confirmed AF detected by MB or HCG-801(Day 14 to Day 28)
- number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy(Day 1 to Day 28)
- number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period(Index Visit up to week 24)
研究者
研究点 (1)
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