Program for Identification of "Actionable" Atrial Fibrillation (PIAAF): Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older: the SCREEN-AF Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 856
- 试验地点
- 28
- 主要终点
- Detection of new atrial fibrillation or flutter
研究概览
简要总结
Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring technologies have the potential to improve early detection of AF. This trial investigates AF screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home blood pressure monitor that has built-in AF screening capability.
详细描述
SCREEN-AF is an investigator-initiated, multicenter, open-label, two-group randomized controlled trial investigating non-invasive, home-based AF screening. The trial targets patients aged 75 years or older with a history of hypertension and without known AF who would be potential anticoagulant candidates if AF were detected. Eligible participants will be recruited from primary care practices and randomly allocated (1:1) to one of two groups:
- The control group will receive standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months).
- The intervention group will undergo ambulatory screening for AF with a 2-week continuous ECG patch monitor worn at baseline and again at 3 months, in addition to standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months). The intervention group will also receive a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring blocks.
The hypothesis is that continuous ambulatory cardiac rhythm monitoring using an adhesive ECG patch monitor will be superior to standard care for AF detection. The overall aim of this research is to establish a practical and cost-effective screening strategy that could be applied in primary care for early detection of AF in patients who would benefit from anticoagulant therapy if AF were detected. The ultimate goal of this primary prevention initiative is to prevent more strokes, and stroke-related deaths, disability, dementia, hospitalizations and institutionalization, through the early detection and treatment of AF.
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
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥75 years without known atrial fibrillation or atrial flutter.
- •The participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).
- •History of hypertension requiring antihypertensive medication.
- •Written informed consent from the participant.
排除标准
- •Any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
- •Implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
- •Likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy <6 months due to concomitant disease.
- •Has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
- •Patient already taking long-term oral anticoagulant therapy.
- •Known allergic reaction/intolerance to skin adhesives.
研究组 & 干预措施
Screening
The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.
干预措施: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP) (Device)
Control
The control group receives standard care for 6 months (including a pulse check and heart auscultation by a physician at 6 months).
结局指标
主要结局
Detection of new atrial fibrillation or flutter
时间窗: within 6 month from randomization
Detection of new AF (atrial fibrillation or atrial flutter) within 6 months post-randomization, with AF defined as at least one episode of continuous AF lasting \>5 minutes or AF documented on at least one 12-lead ECG or a convincing clinical diagnosis of AF based on reliable source documentation.
次要结局
- Detection of other (non-AF) clinically important arrhythmias(within 6 months from randomization)
- Prescription of oral anticoagulation therapy(within 6 months from randomization)
- Adherence, tolerability and patient satisfaction with screening devices(within 6 months of randomization)
- Clinical outcome events(within 6 months from randomization)
- Sensitivity and specificity of Watch BP Home-A monitor ( false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard).(within 6 months from randomization)
- Primary endpoint detected by ECG patch monitor(within 6 months from randomization)
- Atrial fibrillation episodes of various durations (detection of any AF episode ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature)(within 6 months from randomization)
- Cost effectiveness of screening(within 6 months from randomization)