Clinical trial NCT06600620: Intelligent Monitoring to Predict Atrial Fibrillation
Official title: Intelligent Monitoring to Predict Atrial Fibrillation [NOTE-AF]: Clinical Study 1 for the "Health Virtual Twins for the Personalised Management of Stroke Related to Atrial Fibrillation (TARGET)" Project
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation New Onset
Postoperative Cardiovascular Complications
Atrial Fibrillation
Wireless Continuous Vital Signs Monitoring
Keywords: atrial fibrillation
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Copenhagen
name: Isansys Lifecare LTD
name: University of Liverpool
name: Liverpool John Moores University
First posted: 2024-09-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to hospital with a variety of medical conditions

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 \&amp;amp;gt;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\&amp;amp;#39; 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 48 months
Secondary outcomes:
measure: 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
timeFrame: 48 months
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool university foundation trust
city: Liverpool
country: United Kingdom
facility: Liverpool University hospital Foundation trust
Study officials:
References: