Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.
研究概览
简要总结
This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.
A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.
A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.
Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.
详细描述
Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.
All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.
A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
- •12-lead resting ECG confirming sinus rhythm
- •Capacity to consent to study
- •English-speaking
- •Life expectancy at least one year
排除标准
- •Previous diagnosis of AF
- •Recent history of syncope
- •Recent history of cardiac-sounding chest pain
- •A resting ECG suggestive of alternative arrhythmia
- •Inability to use the telephone
- •Thyrotoxicosis
研究组 & 干预措施
Personal Heart Rhythm Monitor
Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
干预措施: Automated Cardiac Event Recorder (Device)
Personal Heart Rhythm Monitor
Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
干预措施: Personal Heart Rhythm Monitor (Device)
结局指标
主要结局
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.
时间窗: 18 months
次要结局
- The sensitivity and specificity of markers of left atrial function to predict PAF.(18 months)
- The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours).(18 months)
- The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.(18 months)
- Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.(30 months)
- The sensitivity and specificity of serum biomarkers to detect cases of PAF.(18 months)
- Stroke reduction in the local area(30 months)
- Referrals to secondary care for suspected AF/palpitations(18 months)
- Participant satisfaction with the devices used in the study.(18 months)