None listed
Conditions
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.
Interventions
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 r
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.
Sponsors
Melbourne Brain Centre at the Royal Melbourne Hospital, the University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with ischemic stroke or transient ischemic attack without known atrial fibrillation presenting to a participating stroke centre
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
Outcome results
None listed