About this trial
Cardiac arrhythmias frequently occur in patients admitted to the Coronary Care Unit (CCU). The majority of these patients are treated for an acute myocardial infarction, which carries an increased risk of life-threatening arrhythmias such as ventricular tachycardia (VT) or ventricular fibrillation (VF). This risk is one of the reasons these patients are monitored for 48 hours after a myocardial infarction, in accordance with the guidelines of the European Society of Cardiology (ESC) for acute coronary syndrome. Other arrhythmias, such as asystole, atrial fibrillation, or atrioventricular block, also occur in CCU patients. These arrhythmias are recorded on the electrocardiogram (ECG) monitor in the CCU and trigger an alarm for healthcare staff. However, in order to apply this alarming with sufficient sensitivity, many false positive alarms are also produced, which increases the workload for nurses (alarm fatigue) and undermines patient well-being.
This study will investigate whether Artificial Intelligence (AI) models, using continuous ECG data, can help improve the prediction of patients at risk of a life-threatening cardiac arrhythmia. Firstly, this study will aim to predict patients at risk of VT/VF in both the short term (30 minutes) and long term (1 day) in patients under continuous telemetric monitoring. This prediction facilitates timely intervention by the team in the short term, and in the long term, the safe transfer of a patient to a lower-complexity ward or earlier safe discharge of a patient. Secondly, this study will aim for improved detection to reduce the number of false negative alarms and thereby reduce alarm fatigue.
The performance of these AI models can be evaluated through this retrospective observational study. Patients aged 18 years or older who have been admitted with acute cardiac disease will be included. The primary objective of this study will be to evaluate the performance of AI models that detect and predict critical arrhythmias in the short and long term, using ECG data obtained via the monitoring system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted from 1/1/2023*
Patients aged 18 years or older
Admitted for acute cardiac illness or after elective cardiac procedures
Who are on ECG monitoring in the CCU, ICU or ward
Disqualifiers
None
Trial population
Patients aged 18 years or older admitted to the Catharina hospital Eindhoven (CZE) with cardiac diseases from 1/1/2023.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Occurrence of sustained ventricular tachycardia or ventricular fibrillation
The primary outcome of the study is the occurrence of sustained ventricular tachycardia (VT) (monomorphic and polymorphic with a heartrate \> 100 bpm and duration \> 30 seconds or with hemodynamic compromise such as fainting or need for resuscitation) or ventricular fibrillation. (Binary outcome measure 0 = no event during admission, 1 = event during admission)
Secondary outcomes
Secondary outcome measure
\- A 'textbook' outcome (no adverse events) (Binary outcome measure 0 = no event during admission, 1 = event during admission)
Secondary Outcome Measure
\- In-hospital onset and offset of cardiac arrhythmias (e.g. atrial fibrillation, atrio-ventricular block or severe tachy- or bradyarrhythmia, non-sustained VT). (Binary outcome measure 0 = no event during admission, 1 = event during admission)
Secondary outcome measure
\- In hospital death/cardiovascular in-hospital death (include cause if available) (Binary outcome measure 0 = no event during admission, 1 = event during admission)
Secondary outcome measure
\- Pulseless electrical activity (PEA) and asystole (Binary outcome measure 0 = no event during admission, 1 = event during admission)
Sponsors and contacts
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