NCT07714109进行中（未招募）不适用
Study on the Compatibility of Twelve-lead Wearable Holter With MRI,CT,X-ray and Echocardiography
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Compliance qualification rate of 12-lead wearable ambulatory electrocardiography with routine imaging examinations
研究概览
简要总结
The 12-lead wearable Holter monitor is compatible with most examinations including MRI, CT, X-ray and echocardiography without compromising data quality. It helps shorten patients' medical visit duration and improves the detection rate of arrhythmias.
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
- •Aged ≥18 years old;
- •Patients requiring MRI, CT, X-ray or cardiac ultrasound examination;
- •Voluntarily wear the 12-lead wearable ambulatory electrocardiography device during imaging examination;
- •Able to understand and sign the informed consent form independently.
排除标准
- •Severe skin damage, infection or allergy on chest skin unable to attach ECG electrodes;
- •Unstable critical condition, emergency rescue state;
- •Permanent magnet-containing implantable devices incompatible with magnetic resonance;
- •Mental disorders or cognitive dysfunction unable to cooperate with examination;
- •Pregnant women.
结局指标
主要结局
Compliance qualification rate of 12-lead wearable ambulatory electrocardiography with routine imaging examinations
时间窗: Within 7 days after enrollment
The proportion of participants with no equipment failure,severe ECG signal interference and related adverse reactions when wearing the 12-lead wearable Holter to receive MRI,CT,X-ray and echocardiography examinations
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Wireless Patch Holter Monitor for Heart Rhythm Tracking: A Validation StudyCTRI/2025/02/081461Sunfox Technologies Private Limited50
尚未招募
不适用
Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of SepsisSepsisNCT07595848Check Point R & D Ltd360
已完成
不适用
ASD Wearables Feasibility StudyWearable DevicesAutism Spectrum DisorderNCT07504224Rady Pediatric Genomics & Systems Medicine Institute40
尚未招募
不适用
Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)Atrial Fibrillation (AF)Heart Failure and Reduced Ejection FractionNCT07687862Beijing Anzhen Hospital818
尚未招募
不适用
Comparing a wearable patch’s vital sign readings with standard hospital devices in patients.CTRI/2025/12/098729Sriram R, Vitritya Private Limited120