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临床试验/NCT02409654
NCT02409654已完成不适用

Randomized Controlled Trial of Tailored Stroke Prevention Strategy for Newly Diagnosed Atrial Fibrillation From a Targeted Screening Program Using Handheld Single-lead ECG Device

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Bryan Ping Yen YAN

Associate Professor

Chinese University of Hong Kong

研究点 (1)

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