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

Cardiotoxicity Clinical Trial

— AI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04885088
• Other study ID #: ShuangHoH
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: YU ANN FANG, MS
• Phone: 886-2-22490088
• Email: runawayyu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• ECG

Intervention

Device:
• Wisdom bracelet
Wisdom bracelet

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Ju-Chi Liu	Lotung Poh-Ai Hospital, Taipei Medical University Hospital, Taipei Medical University WanFang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death, divided into yes or no	Within a year
Primary	heart failure	Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no	Within a year
Primary	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
Primary	Myocarditis	Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no	Within a year
Secondary	Arrhythmia	Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no	Within a year
Secondary	Valvular Heart Disease	Re-hospitalization for Valvular Heart Disease (Judged by the physician) after discharge, divided into yes or no	Within a year
Secondary	Physician adjusts medicine	According to the medicine order issued by the doctor, if there is any adjustment of the medicine, make a record,divided into yes or no	Within a year
Secondary	Physician arranges examination early	If the doctor has arranged to do Cardiac ultrasound or stress & redistribution myocardial perfusion scan with SPECT During non-table period, divided into yes or no	Within a year
Secondary	Compliance	Judged by the physician, when the patient returns to the consultation, the patient is asked about the compliance with the drug in the past, divided into yes or no	Within a year
Secondary	Medical cost	The sum of all medical and health insurance expenses of the patient in the past year	Within a year