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Smart Home Care of Cloud Base ECG on the Cardiotoxicity Prevention on the Cancer Patients. (AI)

2021年5月9日 更新者:Ju-Chi Liu

Thoracic malignancy is the most commonly diagnosed cancer worldwide.1,2 The incidence of thoracic malignancy has decreased in North America, but not in Asia, where it continues to show an increasing trend. A notable manifestation of the bimodal age distribution of thoracic malignancy has been observed in women. The occurrence of early-onset thoracic malignancy in the Asian population is earlier than that in the Western population, resulting in a higher incidence of thoracic malignancy in young Asian women. Moreover, the late onset age distribution of patients with thoracic malignancy in Asia (40-50 years) is earlier than that in Western countries (60-70 years), peaking at the age of 45-50 years in most women. The age-specific incidence rates of thoracic malignancy increase sharply until the menopausal stage.

Cardiovascular morbidity is higher among women with thoracic malignancy involving the thorax who had received radiotherapy (RT) compared with those not involving the thorax but receiving the same treatment. Thus far, the risks and time to onset of cardiac complications have been unclear in both young and old women. The proportion of young women with thoracic malignancy is higher in Asia than in Western countries. Furthermore, whether Asian women with thoracic malignancy are susceptible to RT remains unclear.

Anthracyclines are important therapeutic agents for breast cancer. Anthracycline-based regimens have similar or improved outcomes relative to the standard treatment regimen of cyclophosphamide, methotrexate, and fluorouracil. However, cardiotoxicity is a long-term toxicity associated with these regimens. The combined use of adjuvant anthracycline-based chemotherapy (CT) and RT may result in high cardiotoxicity. Nonetheless, no clear information on the effects of this combined therapy on the time to onset of both cardiac complications and cardiotoxicity is available. Furthermore, whether the cardiotoxicity of adjuvant RT and anthracycline-based CT is associated with age and ethnicity in women with thoracic malignancy remains unclear.

Therefore, cardiovascular disease is undoubtedly one of the most challenging health problems in the world. More efforts are needed to prevent and better control of this disease. Our proposed monitoring program is to use AI to monitor the basal value variation of personalized cardiovascular disease in cancer patients before and after chemoradiation. In the first year, our team focused on cardiotoxicity associated with cardiovascular disease models and cancer treatments. In the second year, we will apply knowledge in a clinical setting and calculate the severity of cardiac toxicity and its incidence and time response after cancer treatment. In the third year, high-risk groups will be identified to provide preventive intervention to reduce the risk of cancer-treatment related cardiotoxicity.

研究概览

详细说明

This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. This study is start on June 1 2021. And will include 400 patients who have just cardiotoxicity of adjuvant RT and anthracycline-based CT patients who diagnosis of Thoracic malignancy. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).

Ask whether the patients who meet the exclusion criteria are willing to participate in the screening (Screening), if they are willing to join and sign the consent of the subject, and after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4 weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The results of these two tests and other basic information of the patient, including Demography, Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association recommended routine test results of high-risk patients, including Blood Chemistry Panel, NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of the logged-in subjects on the paper case report form. The CRF only displays the study number, and no subject is available. In addition to the examination of each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day. After the discharge, the ECG was measured every morning and evening, and their personal activity and sleep were collected. Relevant information. After the subject was discharged from the hospital, the subject tracked the date of all adverse events due to cardiovascular disease within one year, including: heart failure, restenosis due to blood vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the occurrence of death.

研究类型

观察性的

注册 (预期的)

400

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。

学习联系方式

研究联系人备份

  • 姓名:Ju-Chi Liu, PHD, MD
  • 电话号码:8170 886-2-22490088
  • 邮箱liumdcv@tmu.edu.tw

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

20年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Age>=20,Physician diagnosed with Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy.

描述

Inclusion Criteria:

  1. ≥ 20-year-old
  2. Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
  3. Diagnosis of Thoracic malignancy or breast cancer.
  4. Willing to sign the consent form of the subject and cooperate with the return visit
  5. Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination

Exclusion Criteria:

  1. <20-year-old
  2. Can't received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
  3. Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
  4. It is impossible to measure the group of ECG and heart sounds. For example, when using Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.
  5. Patients who are bedridden and have difficulty in cooperating with return visits
  6. Any subject that the physician believes is at high risk for future uncooperative tracking
  7. Direct participants in this program

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

队列和干预

团体/队列
干预/治疗
Interventions

Device: Wisdom bracelet

Other Names:

control group (routine medical)

Wisdom bracelet
control
routine medical Non-invasive Wearable Device
Wisdom bracelet

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
死亡
大体时间:在一年之内
死亡,分为是或否
在一年之内
心脏衰竭
大体时间:在一年之内
出院后因心力衰竭(由医师判断)再次入院,分为是或否
在一年之内
Acute Coronary Syndrome, Coronary Artery Disease
大体时间:Within a year
Come back to the hospital for Acute Coronary Syndrome, Coronary Artery Disease (Judged by the physician) after discharge, divided into yes or no
Within a year
Myocarditis
大体时间:Within a year
Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no
Within a year

次要结果测量

结果测量
措施说明
大体时间
医师调药
大体时间:在一年之内
根据医生开出的药单,如有药物调整,做好记录,分为是或否
在一年之内
医师提早安排检查
大体时间:在一年之内
如果医生已安排做心脏超声或 SPECT 负荷及再分布心肌灌注扫描 在非表期间,分为是或否
在一年之内
遵守
大体时间:在一年之内
由医师判断,当患者回诊时,询问患者以往对药物的依从性,分为是或否
在一年之内
医疗费用
大体时间:在一年之内
患者过去一年的全部医疗和健康保险费用总和
在一年之内
Arrhythmia
大体时间:Within a year
Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no
Within a year
Valvular Heart Disease
大体时间:Within a year
Re-hospitalization for Valvular Heart Disease (Judged by the physician) after discharge, divided into yes or no
Within a year

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。

赞助

调查人员

  • 学习椅:Ju-Chi Liu, PHD, MD、Taipei Medical University Shuang Ho Hospital

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 (预期的)

2021年7月1日

初级完成 (预期的)

2023年6月30日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2021年5月9日

首先提交符合 QC 标准的

2021年5月9日

首次发布 (实际的)

2021年5月13日

研究记录更新

最后更新发布 (实际的)

2021年5月13日

上次提交的符合 QC 标准的更新

2021年5月9日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Wisdom bracelet的临床试验

3
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