QT-Logs : a Clinical Study to Monitor Cardiac Safety, With Artificial Intelligence for QT Interval Analysis of ECG Data From Smartwatches, in Patients Receiving Hydroxychloroquine Treatment for COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Corrected QT (QTc) interval measurement
研究概览
简要总结
This observational pilot prospective study will evaluate a new method for remote monitoring of corrected QT measurement using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches (AI-QTc), in patients ambulatory treated with the HC-AZ combination, at the early stage of COVID-19 infection, at a tertiary hospital center. Daily ECGs will be performed via the smartwatches. AI-QTc will be compared to standard manual QTc reviewed by cardiologist. Correlation and agreement between measures will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •SARS-COV-2 confirmed infection by positive nasopharyngual PCR
- •Prescription of association hydroxychloroquine and azythromycine for COVI-19 therapy
- •Patient's smartphone able to download the smartwatches application
排除标准
- •Presence of a pacemaker
- •Pregnant or breastfeeding females
- •Refusal to participate
- •Incapacity
- •Adult under legal protection (trusteeship, guardianship)
结局指标
主要结局
Corrected QT (QTc) interval measurement
时间窗: 10 days
Measurement of QTc using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches, compare to standard 12 leads ECG reviewed by cardiologist
次要结局
未报告次要终点