|
ISRCTN
|
ISRCTN06487378
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The use of a hand-held electrocardiogram (ECG) monitor to diagnose paroxysmal atrial fibrillation at high risk of stroke
|
|
Scientific title
|
Validation of a single channel, patient-activated, hand-held electrocardiogram (ECG) device (OMRON®) in the diagnosis of paroxysmal atrial fibrillation with high embolic risk
|
|
Acronym
|
NA
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Paroxysmal atrial fibrillation (PAF) predisposes to stroke. It is thought that the longer the duration of PAF the higher the stroke risk. Identification of these individuals, and appropriate management with anticoagulation, should reduce the rate of stroke.
The OMRON® handheld ECG device will diagnose paroxysmal atrial fibrillation, with a high risk of stroke, with a high level of sensitivity and specificity.
|
|
Lay summary
|
Lay summary under review
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Prospective observational study
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Paroxysmal atrial fibrillation (PAF)
|
|
Participants - inclusion criteria
|
1. Age > 65 years
2. Duration of atrial fibrillation > 24 hours in the preceding one month
|
|
Participants - exclusion criteria
|
Cognitive impairment (hence inability to use the handheld ECG device)
|
|
Anticipated start date
|
01/04/2012
|
|
Anticipated end date
|
01/10/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
30
|
|
Interventions
|
Subjects will be issued with two new methods of ECG monitoring (to be compared with the continuous, implantable ECG monitor already in place). The first method will involve twice daily recordings using the hand-held ECG device (OMRON®). This recording will take 30 seconds and will taken for 3 months in total. The second new method will involve a 7 day continuous ECG monitor (the R-test). This will involve wearing a small, discrete ECG monitor around the neck for one week only.
Both these methods are not invasive and hence they should not experience any adverse effects or discomfort.
|
|
Primary outcome measure(s)
|
The accuracy of a hand-held ECG device in the diagnosis of paroxysmal atrial fibrillation as compared to a 'gold-standard' implantable continuous monitoring device
|
|
Secondary outcome measure(s)
|
1. The accuracy of a hand-held ECG device compared to a 7 day continuous ECG monitoring device
2. The concordance of diagnosis of atrial fibrillation using all devices between a trained 'Arrhythmia nurse' and trained Cardiologists
|
|
Sources of funding
|
Stroke Prevention in Atrial Fibrillation (SPAF) Academy (UK) -application in process
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Philippa
Howlett
|
|
Address
|
Department of Cardiology
Royal Surrey County Hospital
|
|
City/town
|
Guilford
|
|
Zip/Postcode
|
GU2 7XX
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Royal Surrey County Hospital (UK)
|
|
Address
|
Egerton Road
|
|
City/town
|
Guildford
|
|
Zip/Postcode
|
GU2 7XX
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.royalsurrey.nhs.uk/
|
|
Date applied
|
24/10/2011
|
|
Last edited
|
29/11/2011
|
|
Date ISRCTN assigned
|
28/11/2011
|
