The IPED (Investigation of Palpitations in the ED) Study | NCT02783898

ID	Type	Description	Link
R15/A164	Other Identifier	Chest Heart Stroke Scotland
PG/17/63/33198	Other Grant/Funding Number	British Heart Foundation

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study	Experimental	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
Control	No Intervention	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.

Name	Type	Description	Arm Group Labels	Other Names
AliveCor Heart Monitor	Device	Smart phone based ECG event recorder	Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Time to Detection of Symptomatic Rhythm

Eligibility Module

Name	Affiliation	Role
Matthew J Reed, MA FRCEM MD	NHS Lothian	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Royal Infirmary of Edinburgh		Edinburgh	Midlothian	EH16 4SA	United Kingdom
Chesterfield

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25918108	Background	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.
24698469

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jun 12, 2018	Sep 16, 2019

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000125 BG001117 BG002242

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00069 OG00111

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

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	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
OG001	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.

Secondary

Time to Detection of Symptomatic Rhythm

Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care

Posted

Mean

Standard Deviation

days

90 days

ID	Title	Description
OG000	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
OG001	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.

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

Posted

Mean

Standard Deviation

days

90 days

ID	Title	Description
OG000	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
OG001	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.

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

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	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
OG001	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.

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

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Study Group	The AliveCor heart monitor was easy to use

Units	Counts
Participants	OG000125

Title	Denominators

Secondary

Financial Cost Per Diagnosis of Symptomatic Rhythm

Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.

Posted

Median

Full Range

British pounds

90 days

ID	Title	Description
OG000	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
OG001	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.

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).

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	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
OG001	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.

Secondary

Number of Participants Completing Questionnaire

Measure of questionnaire compliance - Number of participants completing questionnaire

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Study Group	Questionnaire compliance

Units	Counts
Participants	OG000125

Title	Denominators	Categories

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	124	11	124	0	124
EG001	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.	1	116	1	116	0	116

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Major Adverse Cardiac Events	Cardiac disorders		Systematic Assessment	Number of patients with major adverse cardiac events (MACE; myocardial infarction, life threatening arrhythmia, insertion of pacemaker or internal cardiac defibrillator, insertion of pacing wire).	EG00011 events11 affected124 at risk EG0011 events1 affected116 at risk

Ancestor Terms

ID	Term
D014474	Unconsciousness
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013610	Tachycardia
D000075224	Cardiac Conduction System Disease

ID	Term
D013575	Syncope
D001145	Arrhythmias, Cardiac
D013617	Tachycardia, Supraventricular
D001281	Atrial Fibrillation