Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community
NCT ID: NCT01867060
Last Updated: 2017-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
194 participants
INTERVENTIONAL
2013-05-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Personal Heart Rhythm Monitor
Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
Automated Cardiac Event Recorder
Automated Cardiac Event Recorder to be worn continuously for one week.
Personal Heart Rhythm Monitor
Personal Heart Rhythm Monitor to be used twice-daily for three months.
Interventions
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Automated Cardiac Event Recorder
Automated Cardiac Event Recorder to be worn continuously for one week.
Personal Heart Rhythm Monitor
Personal Heart Rhythm Monitor to be used twice-daily for three months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 12-lead resting ECG confirming sinus rhythm
* Capacity to consent to study
* English-speaking
* Life expectancy at least one year
Exclusion Criteria
* Recent history of syncope
* Recent history of cardiac-sounding chest pain
* A resting ECG suggestive of alternative arrhythmia
* Inability to use the telephone
* Thyrotoxicosis
65 Years
ALL
Yes
Sponsors
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Royal Surrey County Hospital NHS Foundation Trust
OTHER
University of Surrey
OTHER
Responsible Party
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Principal Investigators
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Philippa Howlett, MBChB BSc
Role: PRINCIPAL_INVESTIGATOR
The Royal Surrey County Hospital
Edward Leatham, MBChB MD
Role: STUDY_DIRECTOR
The Royal Surrey County Hospital
Chris Fry, BSc PhD
Role: STUDY_DIRECTOR
The University of Surrey
Locations
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Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, United Kingdom
Countries
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Related Links
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HASTE charity website
Other Identifiers
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HASTE-2
Identifier Type: -
Identifier Source: org_study_id
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