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

NCT ID: NCT04885088

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Artificial Intelligent; Cardiotoxicity; Cardiac Monitor; Cancer Treatment; ECG

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Interventions

Device: Wisdom bracelet

Other Names:

control group (routine medical)

Wisdom bracelet

Intervention Type: DEVICE

Wisdom bracelet

control

routine medical Non-invasive Wearable Device

Wisdom bracelet

Intervention Type: DEVICE

Wisdom bracelet

Interventions

Wisdom bracelet

Wisdom bracelet

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: collaborator

Taipei Medical University Hospital

OTHER

Sponsor Role: collaborator

Lotung Poh-Ai Hospital

OTHER

Sponsor Role: collaborator

Ju-Chi Liu

OTHER

Sponsor Role: lead

Responsible Party

Ju-Chi Liu

MD, PHD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ju-Chi Liu, PHD, MD

Role: STUDY_CHAIR

Taipei Medical University Shuang Ho Hospital

Central Contacts

YU ANN FANG, MS

Role: CONTACT

runawayyu@hotmail.com

886-2-22490088 ext. 8891

Ju-Chi Liu, PHD, MD

Role: CONTACT

liumdcv@tmu.edu.tw

886-2-22490088 ext. 8170

Other Identifiers

ShuangHoH

Identifier Type: -

Identifier Source: org_study_id