NCT07792694 Predict Arrhythmia Risk Using Intelligent Software
| NCT ID | NCT07792694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Catharina Ziekenhuis Eindhoven |
| Condition | Cardiac Arrhythmias |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-01-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion criteria: * 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 * Patients for whom continuous waveform ECG data have been routinely stored. * Continuous waveform ECG data has been routinely stored in the CZE since 1/1/2023 on the ICU, since 1/12/2025 on the CCU and on the ward it has yet to be implemented. As our project utilizes this continuous ECG data, it will only include patients for whom this data is available. Exclusion Criteria: \- Patients who expressed their preference for not having their data used for scientific research or to improve quality of care in the opt-out program of the CZE.
Contact & Investigator
Luuk C Otterspoor, Dr. M.D.
PRINCIPAL INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Frequently Asked Questions
Who can join the NCT07792694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrhythmias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07792694 currently recruiting?
Yes, NCT07792694 is actively recruiting participants. Contact the research team at maud.kortman@catharinaziekenhuis.nl for enrollment information.
Where is the NCT07792694 trial being conducted?
This trial is being conducted at Eindhoven, Netherlands.
Who is sponsoring the NCT07792694 clinical trial?
NCT07792694 is sponsored by Catharina Ziekenhuis Eindhoven. The principal investigator is Luuk C Otterspoor, Dr. M.D. at Catharina Ziekenhuis Eindhoven. The trial plans to enroll 3,000 participants.