Randomized Controlled Trial of Tailored Stroke Prevention Strategy for Newly Diagnosed Atrial Fibrillation From a Targeted Screening Program Using Handheld Single-lead ECG Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Utilization rates of evidence-based stroke prevention therapy
研究概览
简要总结
Stroke is a leading cause of mortality, morbidity and rising healthcare cost worldwide. In 'real-world' practice, AF is often diagnosed too late at time of stroke and detection can be difficult because AF may be present without symptoms and intermittent in nature. Furthermore, utilization of adequate oral anticoagulation therapy (OAC) for stroke prevention is suboptimal in Hong Kong. The challenge is to identify AF prior to occurrence of stroke. The latest European guidelines recommend opportunistic screening for people >=65 years by pulse palpation followed by 12-lead ECG. However, 12-lead ECG requires a trained technician, time consuming, requires the patient to lie on an examination couch and is not readily available in most outpatient clinics in Hong Kong. A practical screening test is needed. Our study aims to evaluate the feasibility, acceptability and incremental cost of an outpatient based AFscreening program using the AliveCor device. Newly diagnosed AF patients will be randomized to routine care versus individualized stroke prevention strategy which consists of patient education, stroke and bleeding risk assessment, evidence-based OAC recommendation, patient audit and follow-up to improve OAC utilization for stroke prevention. We envisage this study will provide timely evidence to inform policy decisions concerning population-based AF-screening for AF for stroke prevention.
详细描述
Study Design
The study consists of 2 stages. The screening study examines the feasibility of screening to identify undiagnosed AF in the elderly (>=65 years) using a validated hand-held ECG device and the impact of screening on clinical and economic outcomes at the population level. Subsequent intervention study is a randomized-controlled study comparing an individualized stroke prevention strategy with routine care to prevent stroke in screen-detected AF patients.
Stage 1: AF Screening Study
Screening will be performed in 2 Cardiology and 4 Family Medicine Specialty Out-Patient Clinics (SOPC) at a tertiary referral hospital in Hong Kong. Subjects who meet inclusion and exclusion criteria will sign informed consent for Stage 1 and 2 studies separately, prior to conducting ECG screening.
Stage 2: Randomized Study of Individualized Stroke Prevention vs. Routine Care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- •Aged 65 years or over
排除标准
- •Severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness)
- •Inability to read/understand the consent form and participation information statement
结局指标
主要结局
Utilization rates of evidence-based stroke prevention therapy
时间窗: 3 years
次要结局
- Clinical outcomes including death, stroke and bleeding(12 months)
- Incremental cost per new AF case detected(3 years)
- Patient awareness questionnaire(12 months)
- Rates of newly diagnosed atrial fibrillation in elderly >65 years of age(3 years)
研究者
Professor Bryan Ping Yen YAN
Associate Professor
Chinese University of Hong Kong
