Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform

Обзор

The WILLEM Registry is a large-scale, single-group, observational, registry study to collect continuous clinical evidence of Willem in real-world settings. Cardiovascular diseases are a major problem for public health and healthcare systems. Electrocardiograms (ECGs) are simple tests which increase diagnostic performance and early detection of cardiovascular diseases. However, its interpretation is complex, time consuming for cardiology experts, and entails high costs for healthcare systems. Willem allows AI-based automatic interpretation and its performance has been examined in previous clinical trials, but additional clinical evidence is needed for its integration in real-world clinical settings. This study will collect clinical evidence of Willem performance to detect cardiac abnormalities in ECGs from high-risk cardiac patients admitted to cardiovascular units.

Подробное описание

Patient enrollment will be both retrospective and prospective.

Вмешательства

• Устройство Willem AI ECG assessment
  There is no study intervention. The Willem AI platform will assess all study ECGs for the identification of cardiac patterns, arrhythmias, and/or cardiac diseases. Regardless of retrospective or prospective enrollment, Willem output will not be provided to the healthcare professional user for clinical evaluation, and therefore routine practice will not be impacted nor altered.

Первичные конечные точки

• Primary endpoint analysis: Willem performance [Срок оценки: From enrollment to any standard of care timepoint when the patient underwent (retrospective) or will undergo within the next 10 years (prospective) an eligible electrocardiogram]

Критерии участия

Критерии включения

• EC/IRB approval of ICF waiver prior to recruitment; otherwise, signed informed consent form by subject and investigator
• Age > 18 years-old, with no upper limit
• Subjects undergoing standard of care electrocardiogram (ECG) of any duration from any hardware device
• All available, but at least one, legible ECG tracings in raw data format (e.g. DICOM, XML, EDF, JSON, HL7, SCP, WFDB, CSV, etc.)
• Available subject clinical data associated with the ECG
• For 12-lead ECGs, a minimum length of 10 seconds at a minimum sample frequency of 250 Hz
• For ECGs from Holters, wearables, patches, insertable cardiac monitors, telemetries, etc., a minimum length of 30 seconds at a minimum sample frequency of 200 Hz with a lead I / II or its MCL-DII lead approximation
• For prospective eligibility only:
• Signed informed consent form, unless previously waived by the EC/IRB
• Site technical viability for ECG and subject clinical data transfer (e.g. end-to-end integration following interoperability standards such as FHIR, HL7 or DICOM)

Критерии исключения

• Unavailable or suboptimal quality of the raw data from the ECG signal
• Age < 18 years-old

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 3 центра

• La Paz University Hospital — Madrid
• Puerta de Hierro University Hospital — Madrid
• Murcia University — Murcia

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Ecuador · 1 центр

• CardioHeredia — Guayaquil

Идентификаторы

NCT: NCT07333547 · WR_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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