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

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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:
Information provided by (Responsible Party):
NHS Lothian

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Presyncope
Arrhythmias, Cardiac
Tachycardia, Supraventricular
Atrial Fibrillation
Intervention Device: AliveCor Heart Monitor
Enrollment 243
Recruitment Details  
Pre-assignment Details 243 patients randomised. 1 participant removed after randomisation as did not meet inclusion criteria. 242 patients allocated to arms.
Arm/Group Title Study Control
Hide Arm/Group Description

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

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.
Period Title: Overall Study
Started 125 117
Completed 124 116
Not Completed 1 1
Arm/Group Title Study Control Total
Hide Arm/Group Description

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

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. Total of all reporting groups
Overall Number of Baseline Participants 125 117 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 117 participants 242 participants
40  (14) 39.1  (13.5) 39.6  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 117 participants 242 participants
Female
74
  59.2%
63
  53.8%
137
  56.6%
Male
51
  40.8%
54
  46.2%
105
  43.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
History of presenting episode = Palpitations  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 117 participants 242 participants
110
  88.0%
109
  93.2%
219
  90.5%
1.Primary Outcome
Title Number of Participants With Symptomatic Rhythm Detection up to 90 Days
Hide Description Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 124 116
Measure Type: Count of Participants
Unit of Measure: Participants
69
  55.6%
11
   9.5%
2.Secondary Outcome
Title Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days
Hide Description Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 124 116
Measure Type: Count of Participants
Unit of Measure: Participants
11
   8.9%
1
   0.9%
3.Secondary Outcome
Title Time to Detection of Symptomatic Rhythm
Hide Description Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 124 116
Mean (Standard Deviation)
Unit of Measure: days
9.5  (16.1) 42.9  (16)
4.Secondary Outcome
Title Time to Detection of Cardiac Arrhythmia Rhythm
Hide Description Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 124 116
Mean (Standard Deviation)
Unit of Measure: days
9.9  (15.6) 48  (0)
5.Secondary Outcome
Title Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 124 116
Measure Type: Count of Participants
Unit of Measure: Participants
12
   9.7%
6
   5.2%
6.Secondary Outcome
Title Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Hide Description Number of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
The AliveCor heart monitor was easy to use
Overall Number of Participants Analyzed 125
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly Agree
48
  38.4%
Agree
32
  25.6%
Missing
33
  26.4%
Strongly Disagree
4
   3.2%
Neutral
8
   6.4%
7.Secondary Outcome
Title Financial Cost Per Diagnosis of Symptomatic Rhythm
Hide Description Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 124 116
Median (Full Range)
Unit of Measure: British pounds
474
(99 to 2697)
1395
(0 to 4161)
8.Secondary Outcome
Title Number of Participants With Serious Outcome up to 90 Days
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 124 116
Measure Type: Count of Participants
Unit of Measure: Participants
11
   8.9%
2
   1.7%
9.Secondary Outcome
Title Number of Participants Completing Questionnaire
Hide Description Measure of questionnaire compliance - Number of participants completing questionnaire
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
Questionnaire compliance
Overall Number of Participants Analyzed 125
Measure Type: Count of Participants
Unit of Measure: Participants
Completed questionnaire
92
  73.6%
Not completed
33
  26.4%
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Control
Hide Arm/Group Description

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

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.
All-Cause Mortality
Study Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/124 (0.00%)      1/116 (0.86%)    
Hide Serious Adverse Events
Study Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/124 (8.87%)      1/116 (0.86%)    
Cardiac disorders     
Major Adverse Cardiac Events  [1]  11/124 (8.87%)  11 1/116 (0.86%)  1
Indicates events were collected by systematic assessment
[1]
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).
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/124 (0.00%)      0/116 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Matt Reed
Organization: NHS Lothian
Phone: +44 131 242 1448
EMail: Matthew.Reed@nhslothian.scot.nhs.uk
Publications:
Layout table for additonal information
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 Submitted: March 23, 2016
First Posted: May 26, 2016
Results First Submitted: September 16, 2019
Results First Posted: November 1, 2019
Last Update Posted: November 19, 2019