Smart Home Care of Cloud Base ECG on the Cardiotoxicity Prevention on the Cancer Patients.
AI
1 other identifier
observational
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMay 13, 2021
May 1, 2021
2 years
May 9, 2021
May 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
death
death, divided into yes or no
Within a year
heart failure
Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no
Within a year
Acute Coronary Syndrome, Coronary Artery Disease
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
Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no
Within a year
Secondary Outcomes (6)
Arrhythmia
Within a year
Valvular Heart Disease
Within a year
Physician adjusts medicine
Within a year
Physician arranges examination early
Within a year
Compliance
Within a year
- +1 more secondary outcomes
Study Arms (2)
Interventions
Device: Wisdom bracelet Other Names: control group (routine medical)
control
routine medical Non-invasive Wearable Device
Interventions
Eligibility Criteria
Age\>=20,Physician diagnosed with Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy.
You may qualify if:
- ≥ 20-year-old
- Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
- Diagnosis of Thoracic malignancy or breast cancer.
- Willing to sign the consent form of the subject and cooperate with the return visit
- Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination
You may not qualify if:
- \<20-year-old
- Can't received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
- Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
- 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.
- Patients who are bedridden and have difficulty in cooperating with return visits
- Any subject that the physician believes is at high risk for future uncooperative tracking
- Direct participants in this program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ju-Chi Liulead
- Taipei Medical University WanFang Hospitalcollaborator
- Taipei Medical University Hospitalcollaborator
- Lotung Poh-Ai Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ju-Chi Liu, PHD, MD
Taipei Medical University Shuang Ho Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PHD
Study Record Dates
First Submitted
May 9, 2021
First Posted
May 13, 2021
Study Start
July 1, 2021
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
May 13, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share