Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001293459
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
14/09/2016
Date last updated
14/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detecting atrial fibrillation, a common heart rhythm abnormality and preventable cause of devastating strokes, using smartphones in patients admitted to hospitals with strokes.
Scientific title
Evaluating the efficacy of smartphone electrographic monitoring for atrial Fibrillation detection in Acute Ischemic Stroke and transient ischemic attack patients
Secondary ID [1] 290046 0
Nil Known
Universal Trial Number (UTN)
U1111-1187-0105
Trial acronym
SPOT AF
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Ischemic stroke 300099 0
Atrial fibrillation 300100 0
Condition category
Condition code
Stroke 299984 299984 0 0
Ischaemic
Cardiovascular 299985 299985 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The AliveCor Mobile ECG device comprise a micro-miniaturised ECG device embedded in a smartphone case and an application (Kardia) compatible with many devices running the Apple iOS and Google Android software. United States Food and Drug Administration and the Australian Therapeutic Goods Administration have approved the AliveCor Mobile ECG device for use as a medical device.

Recording of 30 seconds of ECG equivalent to lead I of 12-lead ECG commences automatically with skin contact when the right and left hands are placed on the electrodes . Cardiac electrical activity is transmitted from the case to the smart phone by ultrasound signal. The Kardia application modulates the signal to a digital ECG trace, which can be viewed in real-time or stored, and is instantly transmitted by the smartphone to a secure server which is Health Insurance Portability and Accountability Act (US HIPAA) confidentiality / privacy standards compliant. The file is stored as a PDF file for physician interpretation accessible through a password-protected website. An automated algorithm in the application produces noise-filtered traces and a computer-averaged complex for AF diagnosis based on criteria of p-wave absence and R-R interval irregularity.

The stroke care unit nursing staff at the participating stroke centres will be trained by the coordinating principal investigator and the local principal investigator on the operation of the
AliveCor Mobile ECG device and the Kardia application prior to study commencement.

Consecutive stroke and transient ischemic attack patients admitted to the stroke care unit at participating stroke centres who fulfil the inclusion and exclusion criteria will receive Intermittent electrocardiographic monitoring administered by the stroke care unit nursing staff at the same frequency as vital observations of pulse and blood pressure using the AliveCor Mobile ECG device until discharge from the stroke care unit. The coordinating principal investigator and the local principal investigator will arrange regular meetings with the stroke care unit nursing staff to monitor the AliveCor Mobile ECG usage during the study. As this is a pragmatic study, no other strategy will be used to improve intervention adherence.
Intervention code [1] 295770 0
Diagnosis / Prognosis
Intervention code [2] 295863 0
Early detection / Screening
Comparator / control treatment
Current standard testing for atrial fibrillation following stroke or transient ischemic attack including 12-lead electrocardiogram, cardiac telemetry and Holter monitoring at each participating stroke centre.
Control group
Active

Outcomes
Primary outcome [1] 299464 0
Proportion of patients with new paroxysmal atrial fibrillation detected using AliveCor Mobile ECG compared to 12-lead ECG, Holter monitoring and cardiac telemetry according to current standard local paradigm.
Timepoint [1] 299464 0
Within 3 months following admission to a participating stroke centre
Primary outcome [2] 299465 0
Proportion of new paroxysmal atrial fibrillation detected using AliveCor Mobile ECG compared to Holter monitoring, in the subset of patients who received Holter monitoring.
Timepoint [2] 299465 0
Within 3 months following admission to a participating stroke centre
Secondary outcome [1] 327260 0
Proportion of new paroxysmal atrial fibrillation detected using AliveCor mobile ECG compared to 12-lead ECG, in the subset of patients who received one or more 12-lead ECG during the admission.
Timepoint [1] 327260 0
Within 3 months following admission to a participating stroke centre
Secondary outcome [2] 327261 0
Proportion of new paroxysmal atrial fibrillation detected using AliveCor mobile ECG compared to cardiac telemetry, in the subset of patients who received cardiac telemetry
Timepoint [2] 327261 0
Within 3 months following admission to a participating stroke centre
Secondary outcome [3] 327263 0
Time from stroke onset to paroxysmal atrial fibrillation detection for AliveCor Mobile ECG, 12-lead ECG, Holter monitoring and cardiac telemetry.
Timepoint [3] 327263 0
Within 3 months following admission to a participating stroke centre
Secondary outcome [4] 327264 0
Proportion of patients who have been prescribed an oral anticoagulant daily (including Vitamin K antagonists, direct thrombin inhibitor and factor Xa inhibitor) by their treating stroke physician or family physician following AliveCor Mobile ECG monitoring compared to 12-lead ECG, 24 Holter monitoring and Cardiac telemetry, as documented in the medical records at the participating stroke centres,
Timepoint [4] 327264 0
Within 3 months following admission to a participating stroke centre

Eligibility
Key inclusion criteria
Patients with ischemic stroke or transient ischemic attack without known atrial fibrillation presenting to a participating stroke centre
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ischemic stroke or transient ischemic attack patients with known atrial fibrillation
2. Patients with isolated sensory change or vertigo without acute infarction on brain imaging

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Repeated monitoring in the same cohort of patients
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimates:

Using the standard settings of two-tailed alpha=0.05, a total sample of 296 patients will yield 80% power to reliably observe the McNemar’s paired proportions test effect size delta=0.04 or higher (Holter monitoring detection) proportion 0.07 and smart phone detection proportion of 0.11), assuming the correlation between devices of 0.65.8 This sample size estimation is conservative as higher values of correlation and hypothesized effect size will lead to lower sample size requirements.

Statistical analyses:

The primary outcome will be tested using the McNemar’s paired proportions test. All continuous variables will be described as mean with standard deviation or median with interquartile range and analysed using either the paired or unpaired t test, the Mann Whitney U test or the Wilcoxon signed-rank test depending on the underlying data distribution and the relationship between the sample populations. Categorical and dichotomized variables will be described as percentages and analysed using either the Fisher’s exact test or the McNemar’s paired proportions test depending on the relationship between the sample populations. Unadjusted outcome effect sizes will be estimated as differences in mean, median (Hodges-Lehmann nonparametric shift) or odds ratio with 95% confidence interval as appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/08/2015
Date of last participant enrolment
Anticipated
30/08/2017
Actual
Date of last data collection
Anticipated
30/11/2017
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA,VIC
Recruitment hospital [1] 6561 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 6562 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 6563 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 14159 0
3050 - Parkville
Recruitment postcode(s) [2] 14160 0
3021 - St Albans
Recruitment postcode(s) [3] 14161 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 8149 0
China
State/province [1] 8149 0
Jiangsu
Country [2] 8150 0
China
State/province [2] 8150 0
Hong Kong

Funding & Sponsors
Funding source category [1] 294415 0
Hospital
Name [1] 294415 0
The Royal Melbourne Hospital
Country [1] 294415 0
Australia
Funding source category [2] 294487 0
Hospital
Name [2] 294487 0
Sunshine Hospital
Country [2] 294487 0
Australia
Funding source category [3] 294488 0
Hospital
Name [3] 294488 0
The Royal Adelaide Hospital
Country [3] 294488 0
Australia
Funding source category [4] 294489 0
Commercial sector/Industry
Name [4] 294489 0
AliveCor Inc.
Country [4] 294489 0
United States of America
Primary sponsor type
Hospital
Name
Melbourne Brain Centre at the Royal Melbourne Hospital, the University of Melbourne
Address
Level 4 Centre, Main Block, the Royal Melbourne Hospital, Grattan Street, Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 293263 0
None
Name [1] 293263 0
Not applicable
Address [1] 293263 0
Not applicable
Country [1] 293263 0
Other collaborator category [1] 279214 0
Hospital
Name [1] 279214 0
Prince of Wales Hospital
Address [1] 279214 0
30 Ngan Shing St, Sha Tin
New Territories, Hong Kong 999077
Country [1] 279214 0
China
Other collaborator category [2] 279215 0
Hospital
Name [2] 279215 0
Nanjing General Hospital of Nanjing Military Command
Address [2] 279215 0
305 East Zhongshan Road, Nanjing
Jiangsu 21002
Country [2] 279215 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295834 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 295834 0
Office for Research
Level 2 South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 295834 0
Australia
Date submitted for ethics approval [1] 295834 0
25/11/2014
Approval date [1] 295834 0
05/03/2015
Ethics approval number [1] 295834 0
HREC/14/MH/358

Summary
Brief summary
BACKGROUND

Stroke is a leading cause of disability and death. Four out of five strokes are due to blockage of blood supply to a part of the brain. Atrial fibrillation (AF) is a common heart rhythm irregularity associated with blood clot formation in the heart that can migrate to the brain and cause strokes. There are proven treatments that can greatly reduce the occurrence of stroke in people with AF. AF can be present intermittently and without any symptoms, therefore can be hard to detect. However, strokes occur just as frequently in people with intermittent AF as in those with continuous AF. Currently stroke sufferers frequently undergo 24 to 48 hours of continuous heart rhythm monitoring using either a non-portable (telemetry) or a portable (Holter) external monitor. However, the cause cannot be determined in a quarter of all strokes despite these tests.

The AliveCor Mobile ECG is a novel device that comprises a smart phone case containing 2 electrocardiogram (ECG) electrodes and a smart phone application that generates 30 seconds of ECG (equivalent to lead I of 12-lead ECG) and automatically diagnose the presence of AF with 97% accuracy. We hypothesize the use of AliveCor Mobile ECG by nurses in the stroke unit will be an effective and inexpensive way to increase in-hospital AF detection following stroke.

AIMS

We aim to compare the number of stroke sufferers with previously undiagnosed intermittent AF that are detected by the AliveCor Mobile ECG to that detected using current standard testing with 12-lead ECG and 24 to 48 hours of Holter monitoring or cardiac telemetry.

PROPOSED RESEARCH DESIGN

Up to 300 consecutive stroke sufferers without known AF admitted to the participating stroke centers will be included in the study. All nurses working in the participating stroke centers will be trained to use the AliveCor Mobile ECG. All participating stroke sufferers will receive checks with the AliveCor Mobile ECG at the same frequency as all their other regular nursing checks from the time they arrive in the participating stroke centers to the time they are well enough to go home or are transferred to another ward or facility. All participating stroke sufferers will also receive all standard heart monitoring available at each participating stroke center.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 68674 0
Dr Hans Tu
Address 68674 0
Melbourne Brain Centre at the Royal Melbourne Hospital
Level 4 Centre, Main Block
Grattan Street, Parkville VIC 3050
Country 68674 0
Australia
Phone 68674 0
+61 3 9349 2477
Fax 68674 0
+61 3 9349 4489
Email 68674 0
[email protected]
Contact person for public queries
Name 68675 0
A/Prof Bernard Yan
Address 68675 0
Melbourne Brain Centre at the Royal Melbourne Hospital
Level 4 Centre, Main Block
Grattan Street, Parkville VIC 3050
Country 68675 0
Australia
Phone 68675 0
+61 3 9349 2477
Fax 68675 0
+61 3 9349 4489
Email 68675 0
[email protected]
Contact person for scientific queries
Name 68676 0
A/Prof Bernard Yan
Address 68676 0
Melbourne Brain Centre at the Royal Melbourne Hospital
Level 4 Centre, Main Block
Grattan Street, Parkville VIC 3050
Country 68676 0
Australia
Phone 68676 0
+61 3 9349 2477
Fax 68676 0
+61 3 9349 4489
Email 68676 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.