Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Paroxysmal Atrial Fibrillation, Stroke

Intervention / Treatment
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* Device: Automated Cardiac Event Recorder
* Device: Personal Heart Rhythm Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Personal Heart Rhythm Monitor<br>Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor. | Device: Automated Cardiac Event Recorder<br>* Automated Cardiac Event Recorder to be worn continuously for one week.<br>* Other names: 'R. Test Evolution 4' (Novacor).;Device: Personal Heart Rhythm Monitor<br>* Personal Heart Rhythm Monitor to be used twice-daily for three months.<br>* Other names: 'Portable ECG monitor HCG-801' (OMRON Healthcare).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 sensitivity and specificity of serum biomarkers to detect cases of PAF. |  | 18 months | 
| The sensitivity and specificity of markers of left atrial function to predict PAF. |  | 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 | 
| Stroke reduction in the local area | A reduction in stroke burden in the local area will be calculated from estimated stroke risk in individuals identified with AF and from a local registry. | 30 months | 
| Referrals to secondary care for suspected AF/palpitations | The number of referrals to secondary care for suspected PAF will be analysed. | 18 months | 
| Participant satisfaction with the devices used in the study. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac monitoring, Biomarkers, Transthoracic echocardiography