NCT03738930Unknown不适用
Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2018年11月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- the incidence of major bleeding during each visit between normal group and smartphone based group
研究概览
简要总结
The present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •age≥18 years, male or female; confirmed acute coronary syndrome patients; undergo percutaneous coronary intervention (PCI) treatment; good command of smart phones agree to participate in this clinical study and sign a written consent form.
排除标准
- •ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; pregnant women or lactating women; investigators consider patients who were not suitable for participation with other reasons
研究组 & 干预措施
normal follow-up group
No Intervention
normal follow-up in ACS patients after PCI
AI based mHealth system follow-up group
Experimental
AI based mHealth system follow-up in ACS patients after PCI. ACS patients in this group will receive message to take more notice to bleeding events.
干预措施: AI based mHealth system (Behavioral)
结局指标
主要结局
the incidence of major bleeding during each visit between normal group and smartphone based group
时间窗: 3 months
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard
次要结局
未报告次要终点
研究者
Yun Dai Chen
Professor
Chinese PLA General Hospital
研究点 (1)
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