Arrhythmias, Cardiac, Atrial Fibrillation, Presyncope, Tachycardia, Supraventricular
Conditions
Keywords
pre syncope, palpitations
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAliveCor Heart Monitor
Smart phone based ECG event recorder
Sponsors
NHS Lothian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant aged 16 years or over 2. Participant presenting with an episode of palpitations or pre-syncope 3. Participant's underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment.
Exclusion criteria
1. Prior diagnostic ECG 2. Palpitations or pre-syncope present during an admission ECG 3. Frequent episodes (i.e. at least once a day) 4. Participants under 16 years of age 5. Previous participation in the study 6. Inability or unwilling to give informed consent. 7. Participants with recent (i.e. within 3 months) myocardial infarction, severe heart failure (NYHA class 4) or unstable angina 8. Participants unwilling or unable to use the AliveCor Heart Monitor and AliveECG app 9. Participants without a compatible smart phone or tablet 10. Participants with cardiac pacemakers or other implanted electronic devices 11. No telephone number for follow-up 12. Participant in custody
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Symptomatic Rhythm Detection up to 90 Days | 90 days | Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Detection of Symptomatic Rhythm | 90 days | Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care |
| Time to Detection of Cardiac Arrhythmia Rhythm | 90 days | Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care |
| Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia | 90 days | Number of participants treated or (planned for treatment) for cardiac arrhythmia in participants using a smart phone based event recorder versus standard care |
| Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days | 90 days | Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care |
| Financial Cost Per Diagnosis of Symptomatic Rhythm | 90 days | Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care. |
| Number of Participants With Serious Outcome up to 90 Days | 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). |
| Number of Participants Completing Questionnaire | 90 days | Measure of questionnaire compliance - Number of participants completing questionnaire |
| Number of Participants Finding the AliveCor Heart Monitor Easy to Use | 90 days | Number of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use |
Countries
United Kingdom
Participant flow
Pre-assignment details
243 patients randomised. 1 participant removed after randomisation as did not meet inclusion criteria. 242 patients allocated to arms.
Participants by arm
| Arm | Count |
|---|---|
| Study All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder | 125 |
| Control All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance. | 117 |
| Total | 242 |
Baseline characteristics
| Characteristic | Study | Control | Total |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 14 | 39.1 years STANDARD_DEVIATION 13.5 | 39.6 years STANDARD_DEVIATION 13.8 |
| History of presenting episode = Palpitations | 110 Participants | 109 Participants | 219 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 74 Participants | 63 Participants | 137 Participants |
| Sex: Female, Male Male | 51 Participants | 54 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 1 / 116 |
| other Total, other adverse events | 0 / 124 | 0 / 116 |
| serious Total, serious adverse events | 11 / 124 | 1 / 116 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study | Number of Participants With Symptomatic Rhythm Detection up to 90 Days | 69 Participants |
| Control | Number of Participants With Symptomatic Rhythm Detection up to 90 Days | 11 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study | Financial Cost Per Diagnosis of Symptomatic Rhythm | 474 British pounds |
| Control | Financial Cost Per Diagnosis of Symptomatic Rhythm | 1395 British pounds |
Secondary
Number of Participants Completing Questionnaire
Measure of questionnaire compliance - Number of participants completing questionnaire
Time frame: 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study | Number of Participants Completing Questionnaire | Completed questionnaire | 92 Participants |
| Study | Number of Participants Completing Questionnaire | Not completed | 33 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study | Number of Participants Finding the AliveCor Heart Monitor Easy to Use | Strongly Agree | 48 Participants |
| Study | Number of Participants Finding the AliveCor Heart Monitor Easy to Use | Agree | 32 Participants |
| Study | Number of Participants Finding the AliveCor Heart Monitor Easy to Use | Missing | 33 Participants |
| Study | Number of Participants Finding the AliveCor Heart Monitor Easy to Use | Strongly Disagree | 4 Participants |
| Study | Number of Participants Finding the AliveCor Heart Monitor Easy to Use | Neutral | 8 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study | Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia | 12 Participants |
| Control | Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia | 6 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study | Number of Participants With Serious Outcome up to 90 Days | 11 Participants |
| Control | Number of Participants With Serious Outcome up to 90 Days | 2 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study | Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days | 11 Participants |
| Control | Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days | 1 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Time to Detection of Cardiac Arrhythmia Rhythm | 9.9 days | Standard Deviation 15.6 |
| Control | Time to Detection of Cardiac Arrhythmia Rhythm | 48 days | Standard Deviation 0 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study | Time to Detection of Symptomatic Rhythm | 9.5 days | Standard Deviation 16.1 |
| Control | Time to Detection of Symptomatic Rhythm | 42.9 days | Standard Deviation 16 |