Smart Home Care of Cloud Base ECG on the Cardiotoxicity Prevention on the Cancer Patients. (AI)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: YU ANN FANG, MS
- Telefoonnummer: 8891 886-2-22490088
- E-mail: runawayyu@hotmail.com
Studie Contact Back-up
- Naam: Ju-Chi Liu, PHD, MD
- Telefoonnummer: 8170 886-2-22490088
- E-mail: liumdcv@tmu.edu.tw
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- <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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Interventions
Device: Wisdom bracelet Other Names: control group (routine medical) |
Wisdom bracelet
|
|
control
routine medical Non-invasive Wearable Device
|
Wisdom bracelet
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
dood
Tijdsspanne: Binnen een jaar
|
dood, verdeeld in ja of nee
|
Binnen een jaar
|
|
hartfalen
Tijdsspanne: Binnen een jaar
|
Kom terug naar het ziekenhuis voor hartfalen (beoordeeld door de arts) na ontslag, verdeeld in ja of nee
|
Binnen een jaar
|
|
Acute Coronary Syndrome, Coronary Artery Disease
Tijdsspanne: 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
Tijdsspanne: Within a year
|
Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no
|
Within a year
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Arts past medicijnen aan
Tijdsspanne: Binnen een jaar
|
Volgens de medicijnbestelling van de arts, als er een aanpassing van het medicijn is, maak dan een record, verdeeld in ja of nee
|
Binnen een jaar
|
|
Arts regelt vroegtijdig onderzoek
Tijdsspanne: Binnen een jaar
|
Als de arts heeft afgesproken om Cardiale echografie of stress & herdistributie myocardiale perfusiescan met SPECT uit te voeren Tijdens niet-tafelperiode, verdeeld in ja of nee
|
Binnen een jaar
|
|
Nakoming
Tijdsspanne: Binnen een jaar
|
Beoordeeld door de arts, wanneer de patiënt terugkeert naar het consult, wordt de patiënt gevraagd naar de naleving van het medicijn in het verleden, verdeeld in ja of nee
|
Binnen een jaar
|
|
Medische kosten
Tijdsspanne: Binnen een jaar
|
De som van alle ziektekosten- en zorgkosten van de patiënt in het afgelopen jaar
|
Binnen een jaar
|
|
Arrhythmia
Tijdsspanne: Within a year
|
Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no
|
Within a year
|
|
Valvular Heart Disease
Tijdsspanne: Within a year
|
Re-hospitalization for Valvular Heart Disease (Judged by the physician) after discharge, divided into yes or no
|
Within a year
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Ju-Chi Liu, PHD, MD, Taipei Medical University Shuang Ho Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ShuangHoH
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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