Clinical trial NCT02783898: The IPED (Investigation of Palpitations in the ED) Study
Official title: Randomised Controlled Trial of the Use of a Smart Phone Based Event Recorder Versus Standard Care for Patients Presenting to the Emergency Department With Palpitations and Pre-syncope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presyncope
Arrhythmias, Cardiac
Tachycardia, Supraventricular
Atrial Fibrillation
Keywords: pre syncope, palpitations
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2016-05-26
Enrollment: 243
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Symptomatic Rhythm Detection up to 90 Days
timeFrame: 90 days
Secondary outcomes:
measure: Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days
timeFrame: 90 days
measure: Time to Detection of Symptomatic Rhythm
timeFrame: 90 days
measure: Time to Detection of Cardiac Arrhythmia Rhythm
timeFrame: 90 days
measure: Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia
timeFrame: 90 days
measure: Number of Participants Finding the AliveCor Heart Monitor Easy to Use
timeFrame: 90 days
measure: Financial Cost Per Diagnosis of Symptomatic Rhythm
timeFrame: 90 days
measure: Number of Participants With Serious Outcome up to 90 Days
timeFrame: 90 days
measure: Number of Participants Completing Questionnaire
timeFrame: 90 days
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Midlothian
city: Chesterfield
country: United Kingdom
facility: Chesterfield
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Royal London Hospital, Barts NHS Trust
city: London
country: United Kingdom
facility: Whipps Cross Hospital, Barts NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
affiliation: NHS Lothian
name: Matthew J Reed, MA FRCEM MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Haberman ZC, Jahn RT, Bose R, Tun H, Shinbane JS, Doshi RN, Chang PM, Saxon LA. Wireless Smartphone ECG Enables Large-Scale Screening in Diverse Populations. J Cardiovasc Electrophysiol. 2015 May;26(5):520-6. doi: 10.1111/jce.12634. Epub 2015 Mar 19.
citation: Tarakji KG, Wazni OM, Callahan T, Kanj M, Hakim AH, Wolski K, Wilkoff BL, Saliba W, Lindsay BD. Using a novel wireless system for monitoring patients after the atrial fibrillation ablation procedure: the iTransmit study. Heart Rhythm. 2015 Mar;12(3):554-559. doi: 10.1016/j.hrthm.2014.11.015. Epub 2014 Nov 18.
citation: Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S, Keating L, Coffey F, Jones L, Harris T, Lloyd G, Gagg J, Smith JE, Coats T. Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study. EClinicalMedicine. 2019 Mar 3;8:37-46. doi: 10.1016/j.eclinm.2019.02.005. eCollection 2019 Feb.
citation: Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S. Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial. Trials. 2018 Dec 29;19(1):711. doi: 10.1186/s13063-018-3098-1.