Paroxysmal Atrial Fibrillation, Stroke
Conditions
Keywords
Cardiac monitoring, Biomarkers, Transthoracic echocardiography
Brief summary
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
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.
Interventions
DEVICEAutomated Cardiac Event Recorder
Automated Cardiac Event Recorder to be worn continuously for one week.
Personal Heart Rhythm Monitor to be used twice-daily for three months.
Sponsors
Royal Surrey County Hospital NHS Foundation Trust
University of Surrey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Stroke reduction in the local area | 30 months | 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. |
| Referrals to secondary care for suspected AF/palpitations | 18 months | The number of referrals to secondary care for suspected PAF will be analysed. |
| Participant satisfaction with the devices used in the study. | 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 | — |
| 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 | — |
| 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 | — |
Countries
United Kingdom
Outcome results
None listed