Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting \>30 seconds to develop risk prediction models to identify patients at high risk for ischaemic stroke.
Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. Among acutely unwell patients; arrhythmias and myocardial injury are common and associated with increased mortality, morbidity, and healthcare costs. Cardiovascular comorbidities in these high-risk patients include hypertension (47%), dyslipidaemia (29%) and ischaemic heart disease (11%). The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting 30 seconds to develop risk prediction models to identify patients at high risk for ischaemic stroke. Data will serve to develop and validate bedside clinical decision support tools and digital twins. Patients who develop episodes of AF as part of acute illness, will suffer further episodes of AF within one year in over 20% of cases with 27% progressing to paroxysmal/permanent AF. The true incidence of AF is unknown in acutely unwell patients as a significant percentage of AF episodes remain undetected with conventional intermittent monitoring. Patients experiencing short self-terminating episodes of AF carry a 5-fold risk of developing continuous AF and double the risk of stroke and thromboembolic events. Patients suffering episodes of AF often remain asymptomatic but are at increased risk of heart failure and death at one year. Compared to routine intermittent manual measurement of vital signs, wireless continuous vital sign monitoring systems (wCVSM) detect deviations instantaneously with the option of alerting clinical staff in real time via mobile phone applications. Accurate categorization of alerts into false and true events is essential for developing intelligent software that can be embedded into monitoring systems. Continuous ECG and vital signs monitoring can detect AF episodes more reliable, trigger timely investigations and support longer term treatment plans. Changes in patient pathways and introduction of novel devices to alert healthcare staff on the potential of clinical events require buy-in from all stakeholders. It is therefore essential to evaluate user acceptance and to determine perceptions of users before rolling out a novel patient pathways or implementation of a new device within an organization. The investigators therefore wish to explore users\' views of the device, wearing the device and potential areas for improvement using questionnaires for patients and health care staff and by conducting semi-structured interviews with healthcare staff. Primary objective To determine the true cardiovascular event rate (defined as at least one of the following criteria: episodes of AF, New Regional Wall Motion Abnormalities, raised cardiac biomarkers hs-troponin T and NT-pro-BNP) versus false cardiovascular events detected by continuous wireless remote monitoring. Secondary objective To determine patient acceptability and usability for health care professionals of a novel remote monitoring device with automated alert function.
Study Type
OBSERVATIONAL
Enrollment
1,200
The investigators will collect data in patients at high risk of atrial fibrillation (AF) without a known history of AF to determine clinical predicators of AF. This data will be used to generate virtual digital twins to to predict clinical and subclinical episodes of AF
Liverpool university foundation trust
Liverpool, United Kingdom
Liverpool University hospital Foundation trust
Liverpool, United Kingdom
To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.
1\) Number of participants with device detected AF lasting greater than 30 seconds
Time frame: 48 months
To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.
Number of episodes of AF and duration of each AF episode
Time frame: 48 months
Length of hospital stay
As measured in days and hours
Time frame: 48 months
Hospital readmissions within 90 days
Number of readmissions and admission diagnosis of hospital readmissions
Time frame: 48 months
Recurrence of AF episodes
Recurrence of AF post discharge as gathered from primary care and secondary care records.
Time frame: 48 months
Hospital and 90-day Mortality
Inhospital and 90-day mortality
Time frame: 48 months
Time spent in AF
Length of time in AF whilst on monitoring device
Time frame: 48 months
Number of AF episodes
Number of AF episodes whilst on monitoring device
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Time frame: 48 months
Complications of AF
Inhospital and 90 day complications of AF such as stroke, thromboembolic disease \& heart failure
Time frame: 48 months
High sensitivity Troponin concentrations in patients with AF episodes
Troponin changes (measured by Hs-Trop T) in patients with episodes of AF
Time frame: 48 months
Echocardiographic changes in patients with AF episodes
As measured by advanced echocardiographic parameters including but not limited to left atrial conduit strain, left atrial booster strain, left atrial stiffness and left atrial strain
Time frame: 48 months
mHealth App Usability Questionnaire
MAUQ score of patients with wireless observations
Time frame: 48 months
Percentage change of troponin concentrations in patients with and without episodes of AF
Change in troponin levels in patients with and without episodes of AF
Time frame: 48 months
Time wireless continuous vital signs monitoring device is attached
Measured in hours and minutes
Time frame: 48 months
Number of cardiovascular alerts
Number of cardiovascular alerts registered by device
Time frame: 48 months
Number of non-cardiovascular alerts
Number of non-cardiovascular alerts registered by device
Time frame: 48 months
Number of alerts reflecting clinical changes
Number of alerts via continuous vital signs monitoring device
Time frame: 48 months
Number of alerts reflecting artefacts or non-clinical events
Number of alerts reflecting clinical deterriorations versus number of alerts reflecting clinical deterrioation
Time frame: 48 months
RWMA score, atrial size and volume, left ventricular strain rate, standard echocardiographic measurements as per british society of echocardiography recommendations
Echocardiographic predictors of AF
Time frame: 48 months
Change in inflammatory markers white cell count, C-reactive protein and procalcitonin over time
Change in blood tests in patients with and without new-onset AF
Time frame: 48 months