Evaluation of an Artificial Intelligence-Enhanced Electrocardiogram Strategy Versus Standard Care to Identify Patients Requiring Cardiac Implantable Electronic Devices: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 11,492
- 试验地点
- 1
- 主要终点
- CIED implantation
研究概览
简要总结
The goal of this clinical trial is to learn whether an artificial intelligence-enhanced electrocardiogram (AI-ECG) strategy improves timely intervention of patients requiring cardiac implantable electronic devices (CIEDs), compared with standard clinical care.
详细描述
This is a randomized controlled trial designed to evaluate the impact of an AI-ECG strategy on the identification of patients requiring CIEDs. The ECGs of eligible participants will be analyzed by a previously validated deep learning algorithm. Those classified as high-risk by the AI-ECG system will be allocated at random into either the intervention group or the control group.
In the intervention group, the physicians will be alerted by the AI-ECG system, and the participants will be proactively contacted to receive ambulatory continuous ECG monitoring for up to 7 days. In the control group, the participants will continue with usual clinical care, and treating physicians will not have access to the AI-ECG results before the end of this study. To ensure accuracy, the reference standards for device indications will be performed by a panel of experienced cardiologists without access to the AI-generated reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one 12-lead ECG within 1 year
排除标准
- •Diagnosis of sick sinus syndrome
- •Diagnosis of high-grade or complete atrioventricular block
- •Diagnosis of ventricular tachycardia or ventricular fibrillation
- •Post CIED implant
- •Heart rate below 40 beats per minute by 12-lead ECG
结局指标
主要结局
CIED implantation
时间窗: Within 180 days after randomization
The number of participants who undergo CIED implantation within the study period. The CIEDs include conventional transvenous pacemakers, leadless pacemakers, and implantable cardioverter-defibrillators (encompassing transvenous, subcutaneous, and extravascular systems).
次要结局
- Number of CIED-Related Complications(Within 90 days after randomization.)
- Number of High-Grade Atrioventricular Block(Within 90 days after randomization)
- Number of Complete Atrioventricular Block(Within 90 days after randomization)
- Number of Sick Sinus Syndrome(Within 90 days after randomization)
- Number of Ventricular Arrhythmia(Within 90 days after randomization)
- Adverse Events Related to Continuous ECG Monitoring(Within 90 days after randomization.)
研究者
Wen-Yu Lin
Associate Professor
National Defense Medical Center, Taiwan