Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually discharged with advice to return to the ED again for a 12-lead ECG should symptoms recur. The investigators will recruit 242 adult participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. Both groups will be followed-up at 90 days. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients with a compatible smart phone or tablet, and revolutionise ED care in this area.
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre syncope (near blackout) are common ED problems sometimes due to an abnormal heart rhythm. Diagnosis is difficult as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually advised to return to the ED for a 12-lead ECG should symptoms recur. The investigators will recruit 242 participants aged 16 years or over presenting to the ED or Medical Assessment Unit of the Royal Infirmary of Edinburgh with an episode of palpitations or pre-syncope and who remain undiagnosed after ED assessment. The investigators will randomise and allocate participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. If a participant allocated to the study arm has palpitations or pre-syncope during the 90-day study period, the participant can record an ECG using the AliveCor Monitor which can be viewed by the study team. Participants will be asked to log symptoms and whether the participant was able to record an ECG during the symptoms in a participant symptom diary, which the participant will return to the research team along with the Participant satisfaction and compliance questionnaire, and smart phone based event recorder at the end of the 90 days in a pre-paid stamped, addressed envelope. Participants will be phoned at 90 days to remind the participant to complete the Participant satisfaction and compliance questionnaire and to return this with the symptom diary and smart phone based event recorder. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
243
Smart phone based ECG event recorder
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom
Chesterfield
Chesterfield, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Royal London Hospital, Barts NHS Trust
London, United Kingdom
Whipps Cross Hospital, Barts NHS Trust
London, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Number of Participants With Symptomatic Rhythm Detection up to 90 Days
Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
Time frame: 90 days
Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days
Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care
Time frame: 90 days
Time to Detection of Symptomatic Rhythm
Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care
Time frame: 90 days
Time to Detection of Cardiac Arrhythmia Rhythm
Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care
Time frame: 90 days
Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia
Number of participants treated or (planned for treatment) for cardiac arrhythmia in participants using a smart phone based event recorder versus standard care
Time frame: 90 days
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Number of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use
Time frame: 90 days
Financial Cost Per Diagnosis of Symptomatic Rhythm
Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.
Time frame: 90 days
Number of Participants With Serious Outcome up to 90 Days
Number of patients with all cause death and/or major adverse cardiac events (MACE; myocardial infarction, life threatening arrhythmia, insertion of pacemaker or internal cardiac defibrillator, insertion of pacing wire).
Time frame: 90 days
Number of Participants Completing Questionnaire
Measure of questionnaire compliance - Number of participants completing questionnaire
Time frame: 90 days
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