The IPED (Investigation of Palpitations in the ED) Study (IPED)

• ClinicalTrials.gov Identifier: NCT02783898
• Recruitment Status: Completed
• First Posted: May 26, 2016
• Results First Posted: November 1, 2019
• Last Update Posted: November 19, 2019
• Sponsor: NHS Lothian
• Information provided by (Responsible Party): NHS Lothian

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Presyncope; Arrhythmias, Cardiac; Tachycardia, Supraventricular; Atrial Fibrillation	Device: AliveCor Heart Monitor	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 243 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Start Date: June 2016
• Actual Primary Completion Date: April 2018
• Actual Study Completion Date: April 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: AliveCor Heart Monitor; Smart phone based ECG event recorder
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Symptomatic Rhythm Detection up to 90 Days [ Time Frame: 90 days ]
   Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.

Secondary Outcome Measures :

1. Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days [ Time Frame: 90 days ]
   Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care
2. Time to Detection of Symptomatic Rhythm [ Time Frame: 90 days ]
   Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care
3. Time to Detection of Cardiac Arrhythmia Rhythm [ Time Frame: 90 days ]
   Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care
4. Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia [ Time Frame: 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
5. Number of Participants Finding the AliveCor Heart Monitor Easy to Use [ Time Frame: 90 days ]
   Number of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use
6. Financial Cost Per Diagnosis of Symptomatic Rhythm [ Time Frame: 90 days ]
   Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.
7. Number of Participants With Serious Outcome up to 90 Days [ Time Frame: 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).
8. Number of Participants Completing Questionnaire [ Time Frame: 90 days ]
   Measure of questionnaire compliance - Number of participants completing questionnaire

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, United Kingdom, EH16 4SA

Chesterfield

Chesterfield, United Kingdom

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Royal London Hospital, Barts NHS Trust

London, United Kingdom

Whipps Cross Hospital, Barts NHS Trust

London, United Kingdom

Nottingham University Hospital

Nottingham, United Kingdom, NG7 2UH

Derriford Hospital

Plymouth, United Kingdom

Royal Berkshire Hospital

Reading, United Kingdom

Musgrove Park Hospital

Taunton, United Kingdom

Sponsors and Collaborators

NHS Lothian

Investigators

• Principal Investigator: Matthew J Reed, MA FRCEM MD; NHS Lothian

  Study Documents (Full-Text)

Documents provided by NHS Lothian:

Statistical Analysis Plan  [PDF] June 12, 2018

Study Protocol  [PDF] October 9, 2016

More Information

Publications:

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: NHS Lothian
• ClinicalTrials.gov Identifier: NCT02783898
• Other Study ID Numbers: 2016/0153; R15/A164 ( Other Identifier: Chest Heart Stroke Scotland ); PG/17/63/33198 ( Other Grant/Funding Number: British Heart Foundation )
• First Posted: May 26, 2016
• Results First Posted: November 1, 2019
• Last Update Posted: November 19, 2019
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by NHS Lothian:

pre syncope, palpitations

Additional relevant MeSH terms:

Syncope; Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Supraventricular; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases