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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：YU ANN FANG, MS
- 電話番号：8891 886-2-22490088
- メール：runawayyu@hotmail.com
研究連絡先のバックアップ
- 名前：Ju-Chi Liu, PHD, MD
- 電話番号：8170 886-2-22490088
- メール：liumdcv@tmu.edu.tw
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Interventions
Device: Wisdom bracelet Other Names: control group (routine medical) |
Wisdom bracelet
|
|
control
routine medical Non-invasive Wearable Device
|
Wisdom bracelet
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
死
時間枠：1年以内に
|
死、はいまたはいいえに分けられる
|
1年以内に
|
|
心不全
時間枠：1年以内に
|
退院後、心不全で再来院（医師の判断）、はい・いいえに分かれる
|
1年以内に
|
|
Acute Coronary Syndrome, Coronary Artery Disease
時間枠：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
時間枠：Within a year
|
Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no
|
Within a year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
医師が薬を調整する
時間枠：1年以内に
|
医師の処方箋に従い、薬の調整があれば、はい・いいえに分けて記録する
|
1年以内に
|
|
医師は早期に検査を手配します
時間枠：1年以内に
|
医師が心臓超音波検査またはストレスと再分布を行うように手配した場合 SPECT による心筋血流スキャン
|
1年以内に
|
|
コンプライアンス
時間枠：1年以内に
|
医師が判断し、患者が診察に戻ると、患者は過去の薬の遵守について尋ねられ、はいまたはいいえに分けられます
|
1年以内に
|
|
医療費
時間枠：1年以内に
|
過去1年間の患者のすべての医療費および健康保険費の合計
|
1年以内に
|
|
Arrhythmia
時間枠：Within a year
|
Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no
|
Within a year
|
|
Valvular Heart Disease
時間枠：Within a year
|
Re-hospitalization for Valvular Heart Disease (Judged by the physician) after discharge, divided into yes or no
|
Within a year
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディチェア：Ju-Chi Liu, PHD, MD、Taipei Medical University Shuang Ho Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。