Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200,000
- 试验地点
- 5
- 主要终点
- Primary endpoint analysis: Willem performance
研究概览
简要总结
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.
详细描述
Patient enrollment will be both retrospective and prospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Unavailable or suboptimal quality of the raw data from the ECG signal
- •Age < 18 years-old
研究组 & 干预措施
High-risk cardiac patients
High-risk cardiac patients undergoing routine care electrocardiogram (ECG) for assessment of arrhythmias or cardiac diseases
干预措施: Willem AI ECG assessment (Device)
Controls
In case of any cardiac disease diagnosed to the high-risk cardiac patient cohort, controls will be any enrolled patient with no confirmed diagnosis of such cardiac disease
干预措施: Willem AI ECG assessment (Device)
结局指标
主要结局
Primary endpoint analysis: Willem performance
时间窗: 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
ECG data will be categorized according to SOC-defined cardiopathies, arrhythmic events, and cardiac diseases. If SOC diagnosis is unavailable or inconsistent, an independent committee of expert cardiologists will review and provide their diagnosis according to a cardiac defined ontology which extends values defined in HL7-aECG data store. Then, the performance of Willem to detect cardiac patterns, arrhythmias, and cardiac disease from ECGs will be assessed. In order to define True Positive, True Negative, False Positive, and False Negative classifications, the ground truth for comparison will be Standard Of Care (SOC) manually performed cardiologist diagnosis. Performance metrics such as diagnostic accuracy, sensitivity, specificity, predictive positive value (PPV), negative predictive value (NPV), F1-Score and Area Under the Receiver Operating Characteristic Curve (AUROC) will be obtained.
次要结局
未报告次要终点