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临床试验/NCT04636996
NCT04636996Unknown不适用

Effects of Artificial Intelligence Assisted Follow-up Strategy Based on a New Remote Contactless Sleep Monitoring System on Secondary Prevention in Patients Received Coronary Artery Bypass Grafting Surgery

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Heart rate

研究概览

简要总结

The present study is trying to find out whether artificial intelligence assisted follow-up strategy will improve secondary prevention in CABG patients. In addition, we will test whether rural patients may have more benefits under the new follow-up strategy based on the artificial intelligence device compared with urban patients.

详细描述

There are a large population of coronary heart disease patients in China, which needs more attention to optimize the secondary prevention and improve the prognosis. Secondary prevention has been showing the effects of improving symptoms, preventing disease progression, improving prognosis, and reducing mortality in patients received coronary artery bypass grafting (CABG) surgery. In this study, we are trying to evaluate the effectiveness of artificial intelligence (AI) assisted follow-up strategy on secondary prevention for patients received CABG surgery. And we are trying to find out whether there is difference in secondary prevention of coronary heart disease between urban and rural patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-70, male or female
  • Received isolated CABG procedure due to coronary artery disease
  • Having a smartphone and are willing to cooperate
  • Signing written informed consent

排除标准

  • Patients undergoing CABG + valve replacement surgery
  • Postoperative hospital stays more than 10 days (Due to limited postoperative follow-up time and unstable condition such as incision infection, angina, etc.)
  • Patients with lung, liver, and kidney failure (Due to organ dysfunction which needs more professional health care and not suitable for this trial)
  • Patients with Urinary system diseases (Getting up during sleep, which will interfere with sleep monitoring)
  • Patients mentally or legally disabled
  • Breastfeeding or pregnant women
  • End-stage disease, estimated survival time is less than 3 months
  • Participate in other perioperative intervention studies at the same time

结局指标

主要结局

Heart rate

时间窗: 35 days

The average heart rate during the first 35 days postoperatively

次要结局

  • Minimum pulse oxygen saturation(35 days)
  • Pain score(35 days)
  • All-cause mortality(35 days)
  • Duration of different sleep stages(35 days)
  • Average Pulse oxygen saturation(35 days)
  • Medication compliance(35 days)
  • Re-admission rate(35 days)
  • Total cost of medical expenses(35 days)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

SHI Jia

Deputy director of the anesthesia center

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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