Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy (APP)
2018年5月22日 更新者：Jiyan Chen、Guangdong Provincial People's Hospital
Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease
Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal application(APP), establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study.
研究概览
详细说明
1.1.Develop and optimize antithrombotic therapy network data platform and thrombotic risk evaluate the intelligent terminal APP, establish a new pattern based on dynamic risk evaluation and event-triggered response, settle the conundrum in clinical practice about antithrombotic therapy such as poor compliance, lag and unreasonable in drug adjustment.
1.2.Settle the technical problem that intelligent terminal APP code isn't compatible with most tablet PCs and smartphones.
1.3.Impel the data platform to render and integrate with the daily medical system, enhance its accuracy, compatibility, privacy, and quality standard.
1.4.Promote the new pattern of anti-thrombotic management by large sample's cohort study, increase the patients' compliance, reduce the readmission rate and adverse event rate of heart and cerebral vessels.
研究类型
介入性
注册 (预期的)
10000
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Guangdong
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Guangzhou、Guangdong、中国
- 招聘中
- Guangdong General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age≥18 years;
- clinical confirmed coronary heart disease. Including definite history of myocardial infarction, stable angina with exercise electrocardiography test(treadmill exercise) positive, unstable angina with electrocardiogram(ECG) ischemic changes or troponin positive, coronary angiography(CAG) hints at least one coronary artery stenoses over 50%, post-operative of percutaneous coronary intervention(PCI) or coronary artery bypass grafting(CABG);
- Be receiving anti-thrombotic therapy;
- Be voluntary to participate in the study., and sign informed consent form.
Exclusion Criteria:
- inability to obtain consent from participants;
- unable to record the medical data through terminal applications(APP)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：APP-assisted anti-thrombotic therapy
Intelligent response system:real-time receiving data or events that doctor or patient terminal upload,then spontaneously evaluate the thrombosis and bleeding risk based on code of point built-in,respectively send messages to doctor and patient after this, then doctors direct the patients to adjust treatment schedule.Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal APP, establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study.
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Applications(APP) support patients to upload the primary data contain pictures and wearable devices data.
When risk-rating changes or serious adverse events(SAE) take place, APP will alert patients to seek medical advice or make a call with the doctor.
Beside, terminal of patients furnishes functions like answering frequently asked questions,self-assessment of physical condition,push rehabilitation knowledge etc.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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adverse clinical events
大体时间：2 years
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net adverse clinical events during 2 years follow-up, including death, myocardial infarction, stroke, ischemia induced target vessel revascularization, BARC type 2-5 bleeding
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2 years
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BRAC 2-5 type bleeding
大体时间：2 years
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defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium（BRAC）
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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heart and cerebral vessels ischemia
大体时间：2 years
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adeverse events of vascular death, myocardial infarction and stroke
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2 years
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readmission
大体时间：2 years
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incidence of readmission during 2-year follow-up
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2 years
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angina recurrence
大体时间：2 years
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incidence of angina recurrence during 2-year follow-up
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2 years
|
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treatment discontinuation
大体时间：2 years
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incidence of treatment discontinuation during 2-year follow-up
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2 years
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drug-related events
大体时间：2 years
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incidence of drug-related adverse reaction during 2-year follow-up
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2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月1日
初级完成 (预期的)
2019年12月30日
研究完成 (预期的)
2020年12月20日
研究注册日期
首次提交
2018年2月27日
首先提交符合 QC 标准的
2018年2月27日
首次发布 (实际的)
2018年3月6日
研究记录更新
最后更新发布 (实际的)
2018年5月24日
上次提交的符合 QC 标准的更新
2018年5月22日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
intelligent terminal APP的临床试验
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University of WashingtonNational Institute of Dental and Craniofacial Research (NIDCR)邀请报名
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Medical University of South CarolinaNational Cancer Institute (NCI)完全的
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Research Center for Clinical Neuroimmunology and...Hoffmann-La Roche; Novartis Pharmaceuticals; University Hospital, Basel, Switzerland; University... 和其他合作者主动，不招人