Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600620
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Intelligent Monitoring to Predict Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOTE-AF
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 ampampgt30 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 paroxysmalpermanent 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 usersampamp39 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
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 paroxysmalpermanent 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 usersampamp39 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None