Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623 EJ, Netherlands
Location status: Recruiting
Location contact
Luuk C Otterspoor, Dr. M.D.
PRINCIPAL_INVESTIGATOR
Maud E Kortman, M.D.
CONTACT
NCT Number: NCT07792694
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Eindhoven, North Brabant, 5623 EJ, Netherlands
Location status: Recruiting
Luuk C Otterspoor, Dr. M.D.
PRINCIPAL_INVESTIGATOR
Maud E Kortman, M.D.
CONTACT
Primary objective:
Assessment of the performances of AI models in identifying patients at risk of sustained VT and VF from bedside monitor ECG in different timeframes:
Secondary objectives:
Exploratory objectives:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During admission
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)
Time frame: During admission
Time frame: during admission
Time frame: During admission
Time frame: During admission
Time frame: During admission
Discrimination of AI prediction model expressed with Area Under the Receiver Operating Characteristic curve (AUROC), Area Under the Precision-Recall Curve (AUPRC), sensitivity, specificity, (Positive Predictive Value) PPV and (Negative Predictive Value) NPV
Contact information is provided by the study sponsor or research team.
Luuk C Otterspoor, Dr. M.D.
CONTACT
Maud E Kortman, M.D.
CONTACT
Catharina Ziekenhuis Eindhoven
Other
Artificial Intelligence-based Prediction and Detection of Critical Arrhythmias in Acute Cardiac Illness.
Acronym: PARIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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