The IPED (Investigation of Palpitations in the ED) Study

Atrial Fibrillation Clinical Trial

— IPED  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783898
• Other study ID #: 2016/0153
• Secondary ID: R15/A164PG/17/63
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2018
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Presyncope
• Syncope
• Tachycardia
• Tachycardia, Supraventricular

Intervention

Device:
• AliveCor Heart Monitor
Smart phone based ECG event recorder

Locations

Country	Name	City	State
United Kingdom	Chesterfield	Chesterfield
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Midlothian
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

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. — View Citation

Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, Albert DE, Freedman SB. iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke. Int J Cardiol. 2013 Apr 30;165(1):193-4. doi: 10.1016/j.ijcard.2013.01.220. Epub 2013 Mar 7. — View Citation

Lowres N, Neubeck L, Salkeld G, Krass I, McLachlan AJ, Redfern J, Bennett AA, Briffa T, Bauman A, Martinez C, Wallenhorst C, Lau JK, Brieger DB, Sy RW, Freedman SB. Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study. Thromb Haemost. 2014 Jun;111(6):1167-76. doi: 10.1160/TH14-03-0231. Epub 2014 Apr 1. — View Citation

Probst MA, Mower WR, Kanzaria HK, Hoffman JR, Buch EF, Sun BC. Analysis of emergency department visits for palpitations (from the National Hospital Ambulatory Medical Care Survey). Am J Cardiol. 2014 May 15;113(10):1685-90. doi: 10.1016/j.amjcard.2014.02.020. Epub 2014 Mar 1. — View 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. — View Citation

Thiruganasambandamoorthy V, Taljaard M, Stiell IG, Sivilotti ML, Murray H, Vaidyanathan A, Rowe BH, Calder LA, Lang E, McRae A, Sheldon R, Wells GA. Emergency department management of syncope: need for standardization and improved risk stratification. Intern Emerg Med. 2015 Aug;10(5):619-27. doi: 10.1007/s11739-015-1237-1. Epub 2015 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	90 days
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	90 days
Secondary	Time to Detection of Symptomatic Rhythm	Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care	90 days
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	90 days
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	90 days
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	90 days
Secondary	Financial Cost Per Diagnosis of Symptomatic Rhythm	Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.	90 days
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).	90 days
Secondary	Number of Participants Completing Questionnaire	Measure of questionnaire compliance - Number of participants completing questionnaire	90 days