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

9. maj 2021 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Interventions

Device: Wisdom bracelet

Other Names:

control group (routine medical)

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
død
Tidsramme: Inden for et år
død, opdelt i ja eller nej
Inden for et år
hjertefejl
Tidsramme: Inden for et år
Kom tilbage til hospitalet for hjertesvigt (bedømt af lægen) efter udskrivelse, opdelt i ja eller nej
Inden for et år
Acute Coronary Syndrome, Coronary Artery Disease
Tidsramme: 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
Tidsramme: Within a year
Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no
Within a year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lægen tilpasser medicin
Tidsramme: Inden for et år
I henhold til lægebekendtgørelsen udstedt af lægen, hvis der er nogen justering af medicinen, skal du lave en registrering, opdelt i ja eller nej
Inden for et år
Lægen arrangerer undersøgelse tidligt
Tidsramme: Inden for et år
Hvis lægen har arrangeret at lave hjerteultralyd eller stress & omfordeling myokardieperfusionsscanning med SPECT Under ikke-bordperiode, opdelt i ja eller nej
Inden for et år
Overholdelse
Tidsramme: Inden for et år
Bedømt af lægen, når patienten vender tilbage til konsultationen, bliver patienten spurgt om overensstemmelsen med lægemidlet i fortiden, opdelt i ja eller nej
Inden for et år
Medicinske omkostninger
Tidsramme: Inden for et år
Summen af ​​alle syge- og sygeforsikringsudgifter for patienten i det forløbne år
Inden for et år
Arrhythmia
Tidsramme: Within a year
Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no
Within a year
Valvular Heart Disease
Tidsramme: Within a year
Re-hospitalization for Valvular Heart Disease (Judged by the physician) after discharge, divided into yes or no
Within a year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studiestol: Ju-Chi Liu, PHD, MD, Taipei Medical University Shuang Ho Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juli 2021

Primær færdiggørelse (Forventet)

30. juni 2023

Studieafslutning (Forventet)

30. juni 2023

Datoer for studieregistrering

Først indsendt

9. maj 2021

Først indsendt, der opfyldte QC-kriterier

9. maj 2021

Først opslået (Faktiske)

13. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Wisdom bracelet

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