Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,174
- 试验地点
- 19
- 主要终点
- Performance of screening tests
研究概览
简要总结
Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.
详细描述
Participants will be screened for AF using three simple methods (pulse check, single-lead ECG, blood pressure machine with automated AF detection algorithms). Subjects screening positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF detected, clinical characteristics and medications will be compared at baseline and 90±14 days later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥65 years.
- •Attending their usual Primary Care Clinic.
- •Provide written informed consent.
排除标准
- •Patients considered by the Investigator to be unsuitable for study follow-up because the patient:
- •is unreliable concerning the follow-up schedule
- •cannot be contacted by telephone
- •has a life expectancy less than the anticipated study duration due to concomitant disease.
- •Presence of an implanted pacemaker or defibrillator.
- •Inability to have a BP cuff applied.
- •Documented significant allergy to ECG electrode adhesive.
- •Previously screened as part of this study.
研究组 & 干预措施
Screening
Subjects will undergo three screening methods for atrial fibrillation:
30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device
干预措施: 30 Second Pulse Check (Other)
Screening
Subjects will undergo three screening methods for atrial fibrillation:
30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device
干预措施: Watch BP Home A (Device)
Screening
Subjects will undergo three screening methods for atrial fibrillation:
30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device
干预措施: HeartCheck Hand-held ECG device (Device)
结局指标
主要结局
Performance of screening tests
时间窗: Baseline visit
The sensitivity and specificity of SL-ECG and BP-AF will be separately compared with that of pulse palpation alone using McNemar's method. This method can be used when only those subjects screening positive attend for confirmatory testing (12-lead ECG ± Holter monitor). A 2-sided alpha of 0.025 will be used to allow for multiple comparisons. A further analysis will be performed using the SL-ECG data as the gold standard. To ensure adequate diagnostic quality, this analysis will only be performed if 5% or less of the overall SL-ECG tracings are deemed "uninterpretable". A bipolar ECG interpreted by a cardiologist has a reported 99% sensitivity and 96% specificity for the diagnosis of AF. If this exploratory analysis is performed it will enable estimation of the sensitivity and specificity of the pulse-check and BP-AF device.
次要结局
- Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints(90 days)
- Cost of each method per case of actionable AF detected(90 days)
- Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.(90 days)
- Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).(90 days)
- Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.(90 days)
- Prescription rates at 90±14 days for oral anticoagulant agents (OACs) and drugs for control of heart rate and/or rhythm for patients with actionable AF(90 days)
- Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.(90 days)
- Stroke or transient ischemic attack rate for each case of actionable AFib identified(90 days)
- Systemic embolism rate for each case of actionable AFib identified(90 days)
- Myocardial infarction rate rate for each case of actionable AFib identified(90 days)
- Significant bleeding rate for each case of actionable AFib identified(90 days)
- Hospitalization due to heart failure rate for each case of actionable AFib identified(90 days)
- Death rate for each case of actionable AFib identified(90 days)
- Time taken for each screening test(Baseline)