Intelligent Monitoring to Predict Atrial Fibrillation
- Conditions
- Atrial Fibrillation New OnsetPostoperative Cardiovascular ComplicationsAtrial FibrillationWireless Continuous Vital Signs Monitoring
- Interventions
- Device: Monitoring patients heart rythms with a wireless patch device
- Registration Number
- NCT06600620
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1200
-
Adult patients ≥50 years
-
Estimated risk of developing new episodes of AF greater than 5%
-
Sinus rhythm at presentation
-
One of the following acute conditions:
- Patients admitted or referred to Critical Care (NOTE-AF ICU)
- Patients admitted to hospital with acute heart failure (NOTE-AF HF)
- Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis)
- Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI)
- Patients post vascular interventions (NOTE-AF Vasc)
- Patients with acute respiratory failure (NOTE-AF Resp)
- Patients admitted after acute stroke (NOTE-AF stroke)
- Atrial fibrillation or atrial flutter at the time of screening
- Patients in atrial fibrillation or atrial flutter at time of preoperative assessment or admission to hospital
- Paced cardiac rhythm
- Inability to obtain consent
- Allergy to plaster or silicone
- Expected hospital stay less than 48 hours
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with acute respiratory failure (NOTE-AF Resp) Monitoring patients heart rythms with a wireless patch device - Patients admitted after acute stroke (NOTE-AF stroke) Monitoring patients heart rythms with a wireless patch device - Patients admitted or referred to Critical Care (NOTE-AF ICU) Monitoring patients heart rythms with a wireless patch device - Patients admitted to hospital with acute heart failure (NOTE-AF HF) Monitoring patients heart rythms with a wireless patch device - Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis) Monitoring patients heart rythms with a wireless patch device - Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI) Monitoring patients heart rythms with a wireless patch device - Patients post vascular interventions (NOTE-AF Vasc) Monitoring patients heart rythms with a wireless patch device -
- Primary Outcome Measures
Name Time Method The incidence of episodes of AF lasting 30 seconds or more in acutely unwell and postoperative patients recorded as part of standard clinical care through extended remote wireless patch-based monitoring with or without the use of an alert system 48 months 1. Number of participants with device detected AF lasting greater than 30 seconds
2. Number of episodes of AF and duration of each AF episode
- Secondary Outcome Measures
Name Time Method To describe the incidence and character of alerts registered by wireless continuous vital signs monitoring devices. To determine patient acceptability and usability for health care professionals of remote monitoring device with automated alert function 48 months 1. To determine the correlation between number of device alerts and occurrence of AF
2. To identify differences in age, gender, length of stay, 30-day mortality, troponin levels, and average National Early Warning (NEWS2) scores in acutely unwell patients
3. To determine the pattern and distribution of AF episodes in acutely unwell patients
4. To identify risk factors for the occurrence of AF episodes
5. To describe the occurrence, incidence and character of alerts registered by wCVSM devices and connected applications
6. Semi-quantitative assessment of patient acceptability
7. Semi-quantitative assessment of acceptability for nursing and healthcare staff
Trial Locations
- Locations (2)
Liverpool university foundation trust
🇬🇧Liverpool, United Kingdom
Liverpool University hospital Foundation trust
🇬🇧Liverpool, United Kingdom